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Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable. Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted. Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice. Discusses applicable laws and regulations supporting GCP compliance, quality and operations. Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.

Power and Sample Size in R guides the reader through power and sample size calculations for a wide variety of study outcomes and designs and illustrates their implementation in R software. It is designed to be used as a learning tool for students as well as a resource for experienced statisticians and investigators. The book begins by explaining the process of power calculation step by step at an introductory level and then builds to increasingly complex and varied topics. For each type of study design, the information needed to perform a calculation and the factors that affect power are explained. Concepts are explained with statistical rigor but made accessible through intuition and examples. Practical advice for performing sample size and power calculations for real studies is given throughout.The book demonstrates calculations in R. It is integrated with the companion R package powertools and also draws on and summarizes the capabilities of other R packages. Only a basic proficiency in R is assumed.Topics include comparison of group means and proportions; ANOVA, including multiple comparisons; power for confidence intervals; multistage designs; linear, logistic and Poisson regression; crossover studies; multicenter, cluster randomized and stepped wedge designs; and time to event outcomes. Chapters are also devoted to designing noninferiority, superiority by a margin and equivalence studies and handling multiple primary endpoints.By emphasizing statistical thinking about the factors that influence power for different study designs and outcomes as well as providing R code, this book equips the reader with the knowledge and tools to perform their own calculations with confidence.Key Features: Explains power and sample size calculation for a wide variety of study designs and outcomes Suitable for both students and experienced researchers Highlights key factors influencing power and provides practical tips for designing real studies Includes extensive examples with R code

Drug Discovery Stories: From Bench to Bedside presents a collection of cases on the development of highly successful pharmaceuticals. It delves into the realm of drug discovery, exploring the structural biology and biological functions of the sought-after targets. The book covers the identification of promising compounds, their transformation from hits to leads through meticulous optimization, and the elucidation of how key compounds interact with the target (in essence, providing invaluable insights for drug design). Additionally, it covers essential information such as the pivotal biological and PK data of lead compounds, any noteworthy clinical results, and a comprehensive overview of other candidate compounds. The field of drug discovery and development has experienced rapid evolution, with numerous new drugs receiving approval each year. While several books have been published on this subject, there is a pressing need for a new book series that accurately reflects the current advancements in drug discovery. This book aims to not only cater to the drug discovery community but also engage other communities involved in chemical biology, synthetic chemistry, and pharmacology. - Analyzes the drug discovery stories of different blockbuster drugs - Includes the newly approved drugs - Covers key aspects related to the drug development of the drugs

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. - Examines trends and recent technologies in dosage, formulation and regulation - Contains contributions from leading experts in academia, research, industry and regulatory agencies - Includes high-quality illustrations, flow charts and tables for easy understanding of concepts - Discusses practical examples and research case studies

Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This'sequential'strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the'druggability'of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term'Safety Pharmacology'was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. &nb

Absorption, Distribution, Metabolism and Excretion (ADME) processes and their relationship with the design of dosage forms and the success of pharmacotherapy form the basis of this upper level undergraduate/graduate textbook. Whereas primarily oriented to Pharmacy students and graduates, it can also be useful for scientist from different fields elated to pharmaceutics and pharmacology. (e.g., material scientists, material engineers, medicinal chemists, physicians) who might be working in a positions in pharmaceutical companies or whose work might benefit from basic training in the ADME concepts and related biological background.Pedagogical features such as objectives, keywords, discussion questions, summaries and case studies are included as teaching tools. This book will provide not only general knowledge on ADME processes but also an updated insight on some hot topics such as drug transporters, multi-drug resistance related to pharmacokinetic phenomena, last generation pharmaceutical carriers (nanopharmaceuticals), in vitro and in vivo bioequivalence studies, biopharmaceuticals, pharmacogenomics, drug-drug and food-drug interactions, in silico and in vitro prediction of ADME properties, or chronopharmacokinetic. In comparison with other similar textbooks, around half of the volume would be focused on the relationship between expanding scientific fields and ADME processes. Each of these burgeoning fields has a separate chapter in the second part of the volume, and is written with experts on the correspondent topic, including industrial scientists and academics from USA and UK.Additionally, each of the initial chapters dealing with the generalities of drug absorption, distribution, metabolism and excretion would include relevant, classic examples related to each topic with appropriate illustrations. ADME Processes and Pharmaceutical Sciences is written as a core textbook for courses on pharmaceutical sciences: pharmacology, pharmacokinetics,drug delivery, biopharmaceutics, drug design and medicinal chemistry courses.

Since 1972, which marks the invention of recombinant engineering, more than 500 therapeutic proteins have been approved for clinical use. Today, biological drugs constitute almost 70% of all new drugs and have a biological origin. The first edition of this book dealt with biosimilars, and this edition (i.e., the second edition) focuses on new drugs, yet limits to therapeutic proteins. Newer technologies for drug development represent the updated topics in the book and include repur-posing, AI- driven identification of newer designs, novel expression systems, manufacturing using these systems, rapidly changing regulatory pathways, and legal hurdles. This edition discusses how to identify, develop, manufacture, and take multibillion dollar products to market within the shortest possible time.Features: Complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins Comprehensive, discovery to market, newer technologies, regulatory planning and IP hurdles are included that are not found elsewhere Expanded volume that must be in the hands of every company interested in biological drugs, including the mRNA-based biopharmaceutical companies fast appearing on the market Discusses how to identify, develop, manufacture, and take multibillion dollar products to market in the shortest possible time Renowned author and entrepreneur in the field of drug discovery and production

After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience.Features: Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.

This book on current approaches to the use of drugs in dentistry, now in an extensively revised second edition, aims to equip practitioners with a sound understanding of both the scientific evidence for various interventions and the comparative efficacy of those interventions. The focus is on the drugs most commonly used in conjunction with dental treatment, including local anesthetics, analgesics, antibiotics, sedatives, and drugs for the management of medical emergencies. Summaries of the scientific evidence from the available published literature are provided, with assessment of the level and quality of the evidence base. A unique aspect of the book is its focus on current, evidence-based recommendations from professional organizations with regard to special topics, such as antibiotic prophylaxis, pediatric considerations, and management of medically compromised patients. Emphasis is placed on evidence from randomized controlled trials, systematic reviews and meta-analyses,and in order to further enhance the up-to-date nature of the book, each chapter includes guidance on online resources, such as useful non-commercial websites.

This book delves into the various aspects of the renin-angiotensin-aldosterone system (RAAS) and its role in cardiovascular disorders. It explores the use of anti-hypertensive agents, with a focus on (ACE) angiotensin-converting enzyme inhibitors and angiotensin receptor blockers (ARBs). The chapters cover topics such as the preferred use of ACE inhibitors over ARBs in high-risk patients, the impact of these agents on insulin resistance, their role in acute heart failure and peripheral artery disease, and their immunomodulatory activity in hypertensive patients. Additionally, the book examines the role of ACE inhibitors and ARBs in COVID-19 patients and provides insights into recent trends in managing hypertension through RAAS inhibition. It serves as a valuable resource for researchers, clinicians, and healthcare professionals involved in the field of cardiovascular medicine.

Pharmaceutical researchers are constantly looking for drug products, drug delivery systems and devices for improving the health of society. A scientific and systematic search for new knowledge requires a thorough understanding of research methods and hypothesis design. This volume presents pharmaceutical research through theoretical concepts, methodologies and ethical issues. It fulfils publication ethics course work requirements for students. Chapters have been designed to cater for the curriculum requirements of universities globally. This serves as a guide on how to apply concepts in designing experiments and transforming laboratory research into actual practice.Features: Complete coverage of research methodology courses for graduate and postgraduate students globally Step-by-step assistance in writing technical reports, projects, protocols, theses and dissertations Experimental designing in pharmaceutical formulation development and preclinical research designs Ethics in using animals in preclinical research and humans in clinical research Publication ethics, best practices and guidelines for ensuring ethical writing Hypothetical and real-world case studies on ethical issues and measures for prevention and control

Concepts and Models for Drug Permeability Studies: Cell and Tissue Based in Vitro Culture Models, Second Edition, summarizes the most important developments in in vitro models for predicting the permeability of drugs. This book is structured around three different approaches, summarizing the most recent achievements regarding models comprising (i) immortalized cells with an intrinsic ability to grow as monolayers when seeded in permeable supports, (ii) primary cells isolated from living organisms and directly cultured as barrier monolayers, and (iii) tissue-based models constructed with cell lines and extracellular matrix that resembles the tridimensional structure of mucosae and other biological membranes, or animal/patient-derived tissues. Each model is covered in detail, including the protocol of generation and application for specific drugs/drug delivery systems. The equivalence between in vitro cell and tissue models and in vivo conditions is discussed, highlighting how each model may provisionally resemble different drug absorption route. Chapters included in the first edition were updated with relevant data published in recent years, while four new chapters were included to reflect new emerging directions and trends in drug permeability models. Concepts and Models for Drug Permeability Studies: Cell and Tissue Based in Vitro Culture Models, Second Edition, is a critical reference for drug discovery and drug formulation scientists interested in delivery systems intended for the administration of drugs through mucosal routes and other important tissue barriers (e.g. the BBB). Researchers studying mucosal biology can use this book to familiarize themselves and exploit the synergic effect of mucosal delivery systems and biomolecules. - Summarizes the current advances in the use of permeability models in drug transport - Covers the most important buccal, gastric, intestinal, pulmonary, nasal, vaginal, ocular, renal, skin, and blood–brain barrier in vitro models. Includes case studies to facilitate understanding of various concepts in computer-aided applications - Updates in the second edition include organ-on-chip devices, 3D advanced models (multiple layered tissues, organoids, etc.), and multicompartmentalized tissue models

Physico-Chemical Aspects of Dosage Forms and Biopharmaceutics: Recent and Future Trends in Pharmaceutics, Volume Two explores aspects of pharmaceutics with an original approach that focuses on technology, novelties and future trends. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. Readers will find practical information for conducting research in pharmaceutics that is ideal for researchers in academia and industry as well as advanced graduate students in pharmaceutics. In addition, the book discusses the most recent developments in biopharmaceutics, including important and exciting areas such as solubility of drugs, pharmaceutical granulation, routes of drug administration, drug absorption, bioavailability and bioequivalence. - Provides extensive details on the most recent developments in biopharmaceutics - Contains contributions from leading experts from academia, research, industry and regulatory agencies - Includes high quality illustrations, flow charts and tables for easier understanding of the concepts - Discusses practical examples and research case studies

This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design.Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

The CTBN volume Therapeutic Applications of Dopamine D3 Receptor Function reviews the state of the knowledge on the dopamine D3 receptor and its role in human behavior and disease (i.e.: neuropsychiatric illnesses including schizophrenia, mood disorders, Parkinson's disease, restless legs syndrome, addictions and substance use disorders). The volume is written by leading experts across multidisciplinary areas (imaging, biobehavioral testing and clinical trials, preclinical models / molecular pharmacology) converging on the therapeutic implications / potential of the D3 receptor.The D3 dopamine receptor is a member of the D2-like family of G protein-coupled receptors. It was cloned and characterized almost 25 years ago. A key feature of the D3 dopamine receptor system, which has attracted considerable attention, is its anatomical localization remarkably restricted to the limbic circuitry. This has spurred the hypothesis that D3 involvement could contribute to the pathophysiology of neuropsychiatric disorders (or to some features of neuropsychiatric disorders), including but not limited to psychosis, addictions and substance abuse, mood and movement disorders.

Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. - Covers how to conduct clinical trials in detail - Present useful, basic, and advanced statistical tools - Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

This book provides a concise overview of recent advances in Pharmacokinetics (PK) and Pharmacodynamics (PD). The pharmacokinetics section covers the state of the art in Physiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2). Chapters 3 and 4 describe the recent development of Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models and their applications to pharmacokinetic data. The pharmacodynamics section focuses on PK/PD modeling. Chapter 5 provides an overview of PK/PD modeling and simulation in clinical practice and studies. Chapter 6 deals with the subject/physiology variability issue encountered in PK/PD studies, while Chapter 7 reviews the influence of clinical pharmacology in the modernization of drug development and regulation. This book is an essential reference for pharmaceutical scientists.

Lantibiotics as Alternative Therapeutics explores alternative therapeutics, lantibiotics and other novel drugs. This book provides concrete information to readers regarding lantibiotics and various types of antimicrobial peptides with their mode of actions in treating various multidrug resistant organisms. It explains various techniques that are involved in analyzing antimicrobial peptides and their mode of actions. The development of antibiotic resistance has now reached a point of crisis where innovative methods and application of novel compounds and methods are required to prevent the spread of drug resistant infections. Novel compounds exhibit different modes of action to the currently used mechanism of therapeutics in order to combat against the resistant organisms. Lantibiotics hold considerable potential as a consequence of their unusual structure, unique mechanisms of action and their potency against multi-drug resistant bacteria. This book will be useful for pharmaceutical industry scientists and researchers in microbial and biomedical research as well as graduate and advanced students in microbiology, medical biotechnology, health, and pharmaceutical sciences. - Includes the biology, molecular interaction with target molecule, putative genes and analytical techniques to isolate and identify compounds - Incorporates relevant case studies to increase understanding - Focuses on recent trends on novel antimicrobial agents and antibiotic resistance research - Discusses new arena of diseases, apart from acute and chronic infections

This fully revised and expanded volume is an effort to blend the common approaches to pharmacokinetics and toxicokinetics. It integrates the principles held in common by both fields through a logical and systematic approach, which includes mathematical descriptions of physical and physiological processes employed in the approaches to pharmacokinetics and toxicokinetics modeling. It emphasizes general principles and concepts and related, isolated applications and case study observations. The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research, scientific or regulatory decisions, or for offering advanced courses/workshops and seminars.Features: Comprehensive handbook on principles and applications of PK/TK appealing to a diverse audience including scientists and students An excellent text fully revised and fully updated for anyone interested in the theoretical and practical pharmacokinetics The systematic compilation of mathematical concepts and methodologies allows readers to decide on relevant concepts and approaches for their research Incorporates research relevant to SDGs and of interest to industrial and regulatory environmental scientists involved in chemical contamination research and regulatory decision making related to soil, water, and ocean Includes sections on applications and case studies

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why'and the ‘how', emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features: Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized Addresses economic and practical considerations, unlike many other technical books Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies Highlights the'why'and the'how', focusing on the need analysis and process modeling and process analytical technologies

Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases.This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines.Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.

Comprehensive Pharmacology, Seven Volume Set is organized into twelve sections that explore therapeutic areas, with a total of 320 comprehensive articles and 6,800 pages of important findings. Sections contain highly detailed coverage of information that has been overseen by an editorial board made up of well-respected, field leading experts. The content in this book offers readers an in-depth and easily accessible reference work on every aspect of pharmacological research surrounding the pharmacology of all therapeutic applications of drugs, their mechanism of action and their therapeutic values. These elements are essential as drugs are almost never tested and developed in the actual therapeutic system, but rather in test systems from which parameters must be determined to predict activity in systems of varying ambient physiology. As different technologies rapidly evolve, there is an ever-increasing level of knowledge about the pharmacology of known drugs, along with increasing capability to utilize pharmacological systems to predict new drug activity, all of which must be communicated to professionals in varying fields. - Contains chapters that follow a consistent and templated approach, resulting in well-structured content that enhances user experience and appeal - Offers a comprehensive review on a wealth of information on pharmacology and how it utilizes concepts and techniques from a broad array of sciences, ranging from chemistry to physiology to medicine - Includes a wider use of color and multimedia content, with interactive features, links, computational modeling and animations to illustrate the effects of toxic substances in various contexts

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence of the COVID-19 virus has brought lung and lung delivery systems into focus, this book covers new developments and research used to address the prevention and treatment of respiratory diseases. Written by well-known scientists with years of experience in the field this timely handbook is an excellent reference book for the scientists and industry professionals.Key Features: Focuses particularly on the chemistry, clinical pharmacology, and biological developments in this field of research. Presents comprehensive information on emerging nanotechnology applications in diagnosing and treating pulmonary diseases Explores drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications Examines specific formulations targeted to pulmonary systems

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

The South African Herbal Pharmacopeia: Monographs of Medicinal and Aromatic Plants is a collection of 25 original monographs of medicinal plants that are currently under commercialization or have the potential for commercialization into herbal medicinal products for the global marketplace. Chapters include a general overview covering synonyms, common names, conservation status, botany, geographical distribution, ethnopharmacology, commercialization, pharmacological evaluation, chemical profiling and quality control, including HPTLC fingerprint analysis, UPLC analysis, gas chromatography and mid-infrared spectroscopy analysis. Academics researching pharmacy and analytical chemistry will benefit from the detailed chemical profile on each species presented. Industrial manufacturers of herbal products, herbal medicines, cosmetics, food supplements, and national and international policymakers and regulators will benefit from the overview provided at the beginning of each chapter. - Provides a comprehensive, up-to-date literature review on 25 medicinal plants of South Africa - Documents quality control protocols for chemical fingerprinting and biomarker identification in plant material - Includes updated safety profiles of medicinal plants

The book titled ‘Prebiotics, Probiotics and Nutraceuticals'is expected to direct many emerging research pathwaysneed at local and global levels for nutrition and food supplements for developing immunity for healthy life. This volume incorporates sixteen seminal papers on issue based research and their practical applications covering latest information and progress on different area of nutritional supplement research fight against disease. The book highlights the frontier issues and applications in nutritional biotechnology with wide coverage of the themes like Potentiality of Probiotics in Inactivation of Tetrodotoxin, Therapeutic Strategy for the Deterrence of COVID-19 with Relevance to Probiotics and Prospectives of Prebiotics, Probiotics and Synbiotics for Sustainable Development in Aquaculture.Plant based Bioactive compounds in Cancer Therapeutics, Recent Trends in Natural Medicines and Nutraceuticals Research, Probiotics as efficacious therapeutic option for treating gut-related diseases: molecular and immune-biological perspectives, The progressive development of probiotics, prebiotics, synbiotics research, and its multipurpose use in the ornamental fishery, The commercial perspective of probiotics, and bioremediating components in aquaculture pond management: A Case Study andPrebiotics as promising therapeutics for treating gut-related disorders : Biochemical and Molecular Perspectives. Prebiotics and Probiotics as Functional Foods: Prospect and Promises in Metabolic Diseases, Implications of probiotics and prebiotics on immune functions. Recent Trends in Natural Medicines and Nutraceuticals Research, Nutraceuticals are alternative to modern medicines, Socio-Economic Study of Prospective of probiotic, prebiotic and synbiotic for sustainable development of aquaculture in Indian Sunderban. This book will be very useful for the scholars, biotechnologists, agricultural scientists, nutritionist, medical doctors, researchers, teachers and students in the emerging field of biotechnology.

There is a growing interest in unmet needs for the development of a new discipline in drug discovery and in university education on polypharmacology. However, there has not been a book with the comprehensive compilation of basic knowledge and advanced methodology that is needed. This book aims to meet the needs making Polypharmacology a new sub-discipline of Pharmacology, not only being a hot area of pharmacological research and education but also a new paradigm for drug discovery. It contains the contents covering the entire scope of Polypharmacology including systemic in-depth exposition of basic knowledge, novel concepts, innovative technologies, and translational and clinical applications by showcasing state-of-the-art strategies and step-by-step instructions of cutting-edge methods. The contents of this book targets broad readerships including scientists in pharmacology research and drug development, and university teachers and graduates in medical school or school of pharmacy.

The ADME Encyclopedia covers pharmacokinetic phenomena (Absorption, Distribution, Metabolism and Excretion processes) and their relationship with the design of pharmaceutical carriers and the success of drug therapies. It covers both basic and advanced knowledge, serving as introductory material for students of biomedical careers and also as reference, updated material for graduates and professionals working in any field related to pharmaceutical sciences (medicine, pharmaceutical technology, materials science, medicinal chemistry). Structured as alphabetically ordered entries with cross-references, the Encyclopedia not only provides basic knowledge on ADME processes, but also detailed entries on some advanced subjects such as drug transporters, last generation pharmaceutical carriers, pharmacogenomics, personalized medicine, bioequivalence studies, biowaivers, biopharmaceuticals, gene delivery, pharmacometrics, pharmacokinetic drug interactions or in silicoand in vitro assessment of ADME properties

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. - Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences - Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics - Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology

Natural products have a long history of use as folk medicines in several systems of traditional medicine. Extensive evidence from modern pharmacological studies has confirmed traditional applications, and unveiled the vast potential of naturally occurring compounds, particularly plant-derived phytochemicals, in the management of chronic human diseases. The past decade has witnessed a surge of findings from randomized controlled trials testifying the safety and efficacy of natural products as adjuncts or alternatives to standard-of-care medications for several illnesses. Biomolecular studies have unveiled hundreds of cellular and molecular targets for phytochemicals including key transcription factors, receptors, enzymes, hormones, neurotransmitters, cytokines, lipids, and non-coding RNAs.Extensive research on the preventative and therapeutic effects of natural products necessitates regular updating of the literature as to the developing potential roles of these compounds in different human diseases. This new book provides an overview of the current pharmacological and clinical features of natural products, and the role of phytopharmaceutical compounds in health and diseases. Chapters cover a wide scope, from cancers, to chronic and age-related disorders, and are written by leading international subject experts. Collectively, chapters will provide useful insights on the regulatory effects of phytochemicals and nutraceuticals on pathogenic molecular signatures associated with pathologies, disease biomarkers, and aging-related pathways.

Medicinal plants and their derived products remain as an indispensable source of bioactive molecules that serve as either drug candidates or lead compounds for drug design and discovery. There are several advantages for plant-derived therapeutics including wide availability, diverse pharmacological actions and a generally good profile of safety and tolerability. Over the recent years, there have been numerous reports from clinical studies testifying to the efficacy and safety of medicinal plants and phytochemicals in ameliorating several human diseases. A plethora of basic studies has also unravelled molecular mechanisms underlying the health benefits of herbal medicines. Nevertheless, issues such as identification of bioactive ingredients, standardization of the products and drug interactions remain to be further studied. In this book, we aim to put together several chapters on the medicinal properties and pharmacological action of medicinal plants, plant species and phytochemicals. The goal is to present a comprehensive collection on most of the therapeutic aspects of plant-derived natural products and molecular mechanisms thereof.

Global Perspectives on Astaxanthin: From Industrial Production to Food, Health, and Pharmaceutical Applications explores the range of practical applications for this molecule, focusing on nutraceutical, pharmaceutical and cosmeceutical products, along with food and feed. This volume brings together the most relevant research, background and future thinking on astaxanthin, focusing on its health benefits. Chapters cover phytopharmaceuticals, industrial production, feeds, downstream processing, regulations, products, color, pigment, cosmetics, bioactive compounds, relationships to other carotenoids, and skin care. The detailed information on its production, processing, utilization and future applications will be of particular use to academic and industry researchers in pharmaceutical sciences, pharmacology and nutrition. - Provides detailed information on astaxanthin, including its production, processing, utilization and future applications - Includes discussion on the commercial analysis procedure - Offers critical analysis on current and potential applications of astaxanthin as contributed by 121 authors from 22 countries in academia, research institutes and industries

Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety. This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes: A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.

The first edition of Pharmacy Practice Research Methods provided a contemporary overview of pharmacy practice research, discussing relevant theories, methodologies, models and techniques. It included chapters on a range of quantitative, qualitative, action research and mixed methods as well as management theories underpinning change in pharmacy practice.This new edition of the book is much broader and more diversified. It includes the quality improvement methods in pharmacy practice research, focusing on the key differences between high and low-income countries with regard to pharmacy practice research, as well as the main challenges faced when conducting such research – areas of significant global interest. In addition, a number of the chapters covering fast-moving fields where new methods have been developed and published have been updated. Featuring seven new topics and presenting future trends, the book also explains in detail methods used in covert and overt observations in pharmacy practice, as well as methods involved in realist research, which are important to countries seeking to produce evidence-based information in this area.

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

All books on the market which have been written on the subject of botulinum toxin therapy focus on treatment of hyperactive movement disorders, autonomic dysfunction (bladder, sweat and salivary glands) and some pain indications (migraine). Reference to pre-or post -surgical indications are brief and often out-dated. No book has information on dentistry or veterinary medicine. This book provides up-to-date information on botulinum toxin therapy in surgical fields. It is also the only book in the market that provides information on botulinum toxin therapy in dentistry and veterinary medicine, furnishing the latest information. Botulinum Toxin Treatment in Surgery, Dentistry, and Veterinary Medicine appeals to many disciplines including surgery, dentistry and veterinary medicines well as appealing to neurologists and internists.

Frontiers in Clinical Drug Research – Diabetes and Obesity is a book series that brings updated reviews to readers interested in advances in the development of pharmaceutical agents for the treatment of two metabolic diseases – diabetes and obesity. The scope of the series covers a range of topics including the medicinal chemistry, pharmacology, molecular biology and biochemistry of natural and synthetic drugs affecting endocrine and metabolic processes linked with diabetes and obesity. Reviews in this series also include research on specific receptor targets and pre-clinical / clinical findings on novel pharmaceutical agents. Frontiers in Clinical Drug Research – Diabetes and Obesity is a valuable resource for pharmaceutical scientists and postgraduate students seeking updated and critically important information for developing clinical trials and devising research plans in the field of diabetes and obesity research.The fifth volume of this series features 5 reviews which are informative guides to therapy and drug administration in diabetes and metabolic syndrome, for both the medical specialist and the pharmacologist.-Metabolic syndrome in schizophrenia-Insulin therapy and foetoplacental endothelial dysfunction in gestational diabetes mellitus-Insights on diabetes, oxidative stress and antioxidant therapeutic strategies-Administration of nano drugs in the treatment of diabetes mellitus-SGLT-2 inhibitors

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions.About the authorShein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-MyersSquibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Drug Delivery Systems examines the current state of the field within pharmaceutical science and concisely explains the history of drug delivery systems, including key developments. The book translates the physicochemical properties of drugs into drug delivery systems administered via various routes, such as oral, parenteral, transdermal and inhalational. Regulatory and product development topics are also explored. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of drug delivery systems within the pharmaceutical sciences industry and research, as well as in chemical engineering. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists. This book provides a comprehensive examination that is suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnologies, and related industries. - Provides up-to-date information on how to translate the physicochemical properties of drugs into drug delivery systems - Explores how drugs are administered via various routes, such as oral, parenteral, transdermal and inhalational - Contains extensive references and further reading for course and self-study

The Psychopharmacologists 3 completes a trio of interview-based books about the process of therapeutic innovation in clinical psychiatry. David Healy's method is to interview key individuals involved in the discovery and deployment of drugs that have proved useful to psychiatry, and to draw them together within a model of the mechanism and clinical discovery that he uses as an overall framework.These are historical accounts but highly relevant to the clinical psychiatrist of today, emphasising the importance of research, and of the marketing strategies of pharmaceutical companies in formulating disease entities as well as treatments for them.

The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc.Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers.Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided.Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

First Published in 1989, this book offers a full, comprehensive guide into the role of Dopamine in the Periphery. Carefully compiled and filled with a vast repertoire of notes, diagrams, and references this book serves as a useful reference for Students of Medicine, and other practitioners in their respective fields.

First published in 1995: Combining the established disciplines of pharmacokinetics (PK), the relationship between drug concentration and time, and pharmacodynamics (PD), the relationship between drug effects and concentration, this handbook examines the relevant relationship between drug effects and time.