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Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Towards a better understanding of how medicines are used in society Drug Utilization Research (DUR) is a discipline which combines aspects of pharmacotherapy, epidemiology, and health services research into an interdisciplinary set of methods for analyzing and assessing the prescribing, dispensing and consumption of medicines. It combines both qualitative and quantitative approaches to facilitate the safe and effective use of pharmaceuticals. Drug Utilization Research: Methods and Applications provides a comprehensive introduction to this discipline, prepared by an international team of authors with broad experience in numerous fields. Now reorganized and updated to reflect the latest research and global challenges, it is an indispensable resource for understanding the use of pharmaceuticals. Readers of the second edition of Drug Utilization Research will find: New chapters on methods, including more hands-on guidance on how to plan and conduct different types of drug utilizationA section on specific applications in areas such as psychotropics, opioids, cancer drugs, antibacterials, and cardiovascular drugsA new section with case studies illustrating applications of DUR in different continentsDetailed treatment of subjects including DUR and health policy, DUR in specific populations, and many more Drug Utilization Research is ideal for epidemiologists, pharmacists, physicians, nurses and others interested in drug use and its outcomes.

Highly comprehensive and detailed text on best possible sustainable approaches associated with the development, design, and origination of pharmaceuticals Sustainable Approaches in Pharmaceutical Sciences enables readers to understand the best possible green approaches associated with the development, design, and origination of pharmaceuticals, including resources that may minimize the adverse effects associated with synthesis, isolation, and extraction. Sustainable Approaches in Pharmaceutical Sciences covers a myriad of current topics, including mechanochemical improvements for API synthesis, as well as the role of artificial intelligence (AI) in the development and discovery of pharmaceuticals, along with recent developments in hydrogels which respond to triggered factors during topical drug delivery. Authored by experienced scientists from institutions across the world, other sample topics covered in Sustainable Approaches in Pharmaceutical Sciences include: Green technologies and benefits associated with them, white biotechnology, green chemistry, and eco-friendly approaches for designing active pharmaceutical ingredients Impact of sustainable approaches in pharmaceutical industries regarding use of solvents, nanoparticles formulations, and antimicrobial bandages Micro-extractive methods capable of generating high recovery values of the analytes and associated techniques, such as dispersive liquid-liquid microextraction Benefits of the exploration of sustainable chemistry on a commercial scale, particularly in relation to bioresources, chemical manufacturing, and organic transformationDiscussing both the foundational science and practicality of different approaches regarding human and environmental health, Sustainable Approaches in Pharmaceutical Sciences is an essential resource for scientists, medical professionals, and industrial professionals working in the fields of sustainable technology and synthesis in pharmaceutical sciences, along with advanced level students.

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author's years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use. Strom's Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in “the real world,” who will respond to the challenges that they encounter.

DIABETES DRUG NOTES Diabetes is becoming more common in both older and younger generations and in keeping with this escalation in cases, there are an ever increasing number of drugs and drug classes that are suitable to treat hyperglycaemia. In a unique blend of diabetes practice, clinical pharmacology, and cardiovascular medicine, Diabetes Drug Notes describes the principles of clinical pharmacology with regards to diabetes prescribing. Each drug class for the treatment of diabetes is covered in detail, along with the effect on the cardiovascular and renal systems caused by each drug. Building upon the success of their “Drug Notes” series for Practical Diabetes and their “Drugs for Diabetes” series in the British Journal of Cardiology, the team of experts focuses on the glycaemic management of type 1 and type 2 diabetes, with other effects of antidiabetic drugs covered as well. Diabetes Drug Notes also includes: Comprehensive and up-to-date coverage of the drugs for the glycaemic management of patients with type 1 or type 2 diabetes Expert reflection on prescribing considerations for special groups, as well as common pitfalls in prescribing Detailed case histories to illustrate relevant information Summaries of recent guidelines related to diabetic intervention Diabetes Drug Notes is a user-friendly guide for a general diabetes medical, nursing, and pharmacology readership, as well as those who support them.

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.

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

A practical introduction to epidemiology, biostatistics, and research methodology for the whole health care community This comprehensive text, which has been extensively revised with new material and additional topics, utilizes a practical slant to introduce health professionals and students to epidemiology, biostatistics, and research methodology. It draws examples from a wide range of topics, covering all of the main contemporary health research methods, including survival analysis, Cox regression, and systematic reviews and meta-analysis—the explanation of which go beyond introductory concepts. This second edition of Quantitative Methods for Health Research: A Practical Interactive Guide to Epidemiology and Statistics also helps develop critical skills that will prepare students to move on to more advanced and specialized methods. A clear distinction is made between knowledge and concepts that all students should ensure they understand, and those that can be pursued further by those who wish to do so. Self-assessment exercises throughout the text help students explore and reflect on their understanding. A program of practical exercises in SPSS (using a prepared data set) helps to consolidate the theory and develop skills and confidence in data handling, analysis, and interpretation. Highlights of the book include: Combining epidemiology and bio-statistics to demonstrate the relevance and strength of statistical methods Emphasis on the interpretation of statistics using examples from a variety of public health and health care situations to stress relevance and application Use of concepts related to examples of published research to show the application of methods and balance between ideals and the realities of research in practice Integration of practical data analysis exercises to develop skills and confidence Supplementation by a student companion website which provides guidance on data handling in SPSS and study data sets as referred to in the text Quantitative Methods for Health Research, Second Edition is a practical learning resource for students, practitioners and researchers in public health, health care and related disciplines, providing both a course book and a useful introductory reference.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

The assessment of patient reported outcomes and health-related quality of life continue to be rapidly evolving areas of research and this new edition reflects the development within the field from an emerging subject to one that is an essential part of the assessment of clinical trials and other clinical studies.The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical practice.

Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.

Highly Commended in Medicine in the 2017 BMA Medical Book AwardsEssential Practical Prescribing is an important new textbook with a clinical, ward-based focus. It is specifically designed to help new foundation doctors working on the hospital wards and in the community, as well as medical students preparing for the Prescribing Safety Assessment. Using an accessible format, Essential Practical Prescribing demonstrates how to manage common medical conditions, and explains the logic behind each decision. It also emphasises common pitfalls leading to drug errors, and highlights drugs that could cause harm in certain situations. Organised by hospital department, it outlines the correct management of conditions, as well as highlighting the typical trials of a junior doctor. Essential Practical Prescribing: Contains a range of learning methods within each chapter including: key topics, learning objectives, case studies, DRUGS checklists,'Top-Tips', advice on guidelines and evidence, and key learning points Uses patient histories to set the scene and enhance the clinical emphasis Offers examples of correctly completed drug charts throughout, which are also available online Is an ideal companion for Prescribing Safety Assessment (PSA) preparation Includes a companion website at www.wileyessential.com/prescribing featuring MCQs and downloadable DRUGS checklists and drug charts

Ibuprofen has become one of the foremost pain-relieving medications world-wide with its proven safety and efficacy in a wide variety of painful and inflammatory conditions. It has also been widely investigated for application in a variety of painful and non-pain inflammatory states including cancer and neurodegenerative conditions, reflecting the unique and novel properties of the drug that would never have been foreseen from knowledge of the properties when it was initially discovered. Edited by leading world expert with over 40 years record in research, teaching and as a scientific advisor in the field of anti-inflammatory/analgesic agents. Professor Kim Rainsford is also the founding Editor-in-Chief of the journal, Inflammopharmacology, as well as being an Associate Editor of The Journal of Pharmacy & Pharmacology. Provides a thorough coverage of the medicinal chemistry and pharmaceutics of ibuprofen, and its pharmacokinetics in both humans and animals. Includes molecular, pharmacological and toxicological studies, and discusses the safety and efficacy of non-prescription ibuprofen, including its side effects. Ibuprofen: Discovery, Development & Therapeutics provides a definitive reference on all the main aspects of the chemical and pharmaceutical properties, mechanisms of action and therapeutic uses of ibuprofen including its role in the prevention and treatment of rheumatic conditions, cancer and neurodegenerative conditions such as Alzheimer's and Parkinson's diseases. The book has its origins in a volume first published in 1999, since when there have been considerable advances in research and clinical studies on ibuprofen in the treatment of many inflammatory and even non-inflammatory states. This book will prove invaluable to scientists, clinicians, pharmacists and all those who need to know about the actions and uses of anti-inflammatory and analgesic drugs.

Ethnopharmacology is one of the world's fastest-growing scientific disciplines encompassing a diverse range of subjects. It links natural sciences research on medicinal, aromatic and toxic plants with socio-cultural studies and has often been associated with the development of new drugs. The Editors of Ethnopharmacology have assembled an international team of renowned contributors to provide a critical synthesis of the substantial body of new knowledge and evidence on the subject that has emerged over the past decade. Divided into three parts, the book begins with an overview of the subject including a brief history, ethnopharmacological methods, the role of intellectual property protection, key analytical approaches, the role of ethnopharmacology in primary/secondary education and links to biodiversity and ecological research. Part two looks at ethnopharmacological contributions to modern therapeutics across a range of conditions including CNS disorders, cancer, bone and joint health and parasitic diseases. The final part is devoted to regional perspectives covering all continents, providing a state-of-the –art assessment of the status of ethnopharmacological research globally. A comprehensive, critical synthesis of the latest developments in ethnopharmacology. Includes a section devoted to ethnopharmacological contributions to modern therapeutics across a range of conditions. Contributions are from leading international experts in the field. This timely book will prove invaluable for researchers and students across a range of subjects including ethnopharmacology, ethnobotany, medicinal plant research and natural products research. Ethnopharmacology- A Reader is part of the ULLA Series in Pharmaceutical Sciences www.ullapharmsci.org

Essential Statistics for the Pharmaceutical Sciences is targeted at all those involved in research in pharmacology, pharmacy or other areas of pharmaceutical science; everybody from undergraduate project students to experienced researchers should find the material they need. This book will guide all those who are not specialist statisticians in using sound statistical principles throughout the whole journey of a research project - designing the work, selecting appropriate statistical methodology and correctly interpreting the results. It deliberately avoids detailed calculation methodology. Its key features are friendliness and clarity. All methods are illustrated with realistic examples from within pharmaceutical science. This edition now includes expanded coverage of some of the topics included in the first edition and adds some new topics relevant to pharmaceutical research. a clear, accessible introduction to the key statistical techniques used within the pharmaceutical sciences all examples set in relevant pharmaceutical contexts. key points emphasised in summary boxes and warnings of potential abuses in ‘pirate boxes'. supplementary material - full data sets and detailed instructions for carrying out analyses using packages such as SPSS or Minitab – provided at:https://www.wiley.com/go/rowe/statspharmascience2e An invaluable introduction to statistics for any science student and an essential text for all those involved in pharmaceutical research at whatever level.

Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.

Drug abuse has been, and continues to be, a global societal issue with diverse sets of impacts. Drugs of Abuse: Pharmacology and Molecular Mechanisms introduces the basic principles of pharmacology and neuroscience of drug abuse. Understanding the chemistry of commonly abused drugs and their impact on brain function will provide students and researchers with a more profound understanding of the molecular basis of drug abuse and addiction. Drugs of Abuse: Pharmacology and Molecular Mechanisms opens with a brief history of drug use and abuse. Subsequent sections look at specific families of drugs, including stimulants, depressants, and hallucinogens among others, and explore how their chemical make-up interacts with brain function. The final chapter provides a brief overview of clinical substance abuse treatment. Providing a concise, accessible introductory overview of the topic, Drugs of Abuse: Pharmacology and Molecular Mechanisms will be a valuable resource for students, researchers, and others interested in how drugs interact with the brain. Introduces readers to the basic principles of neuroscience and pharmacology as related to drug use and abuse. Explores how the chemical make-up of drugs interact with the brain and can lead to addiction Includes coverage of a wide array of commonly abused families of drugs, including stimulants, depressants, hallucinogens, and others. Provides an essential introduction to the chemical and molecular underpinnings of drug use and abuse

Prescribing at a Glance The market-leading at a Glance series is used world-wide by medical students, residents, junior doctors and health professionals for its concise and clear approach and superb illustrations. Each topic is presented in a double-page spread with clear, easy-to-follow diagrams, supported by succinct explanatory text. Covering the whole medical curriculum, these introductory texts are ideal for teaching, learning and exam preparation, and are useful throughout medical school and beyond. Everything you need to know about Prescribing...at a Glance! The principles of drug therapies are fundamental to medical practitioners in all branches; but are often difficult to get to grips with. Prescribing at a Glance addresses the most common uses of prescription drugs, and follows progress from dose calculation and administration to monitoring the effects in the treatments of major presenting problems. With a focus on prescribing, this user-friendly guide helps practitioners to develop crucial knowledge and skills, including establishing accurate drug histories, planning appropriate therapies, writing safe and legal prescriptions, critically appraising the prescribing of others, patient support, accessing reliable information about medicines, and detecting adverse drug reactions. Prescribing at a Glance: Features detailed and high-quality colour illustrations throughout Includes examples of common prescribing errors, practice prescriptions and calculations Follows the structure of the WHO Good Prescribing Guide, and corresponds to the core curriculum of the British Pharmacological Society Is the perfect guide to help you prepare for the Prescribing Skills Assessment (PSA) From the series that brought you Medical Pharmacology at a Glance, and designed to help those in the later stages of their medical training become adept at the skills required for a vital yet often confusing subject, Prescribing at a Glance will help you fill in any knowledge gaps with simple step-by-step instructions, and clear, easy- to-remember guidelines. All content reviewed by students for students Wiley-Blackwell Medical Education books are designed exactly for their intended audience. All our books are developed in collaboration with students, which means our books are always published with you, the student, in mind.

Prescribing Scenarios at a Glance is an innovative resource which allows medical students and junior doctors to practise prescribing skills safely for themselves. Supporting those who wish to develop their prescribing knowledge and clinical reasoning, this book features 50 acute and on call scenarios in a hospital setting. Users will be able to practise skills such as initiating a prescription, planning management, reviewing therapy, and identifying adverse drug reactions and interactions. Prescribing Scenarios at a Glance: • Contains case scenarios, mock drug charts and model answers with discussion • Features a workbook of prepared drug charts for each case that allow users to practise prescription writing • Includes detailed explanations and answers to all case scenarios, including examples of correctly completed charts • Includes access to refill drug charts for each scenario available on the companion website at www.ataglanceseries.com/prescribingscenarios, allowing users to rehearse each scenario as many times as they like An ideal companion for medical students, foundation doctors and non-medical prescribers as they develop their prescribing skills, this book will help to instil confidence, reduce errors, and encourage best practice. It will also be a valuable resource for candidates preparing for prescribing exams.This title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from iTunes, Google Play or the MedHand Store.

Textbook of Pharmacoepidemiology, Second Edition, provides an introduction to pharmacoepidemiology and the data sources, methods and applications used in clinical research, the pharmaceutical industryand regulatory agencies. Drawing upon the fifth edition of the authoritative reference, Pharmacoepidemiology, this new edition covers the key learning requirements of the discipline. The textbook provides an introduction topharmacoepidemiology, pharmacoepidemiological data sources, special issues in methodology, special applications and future developments in the field. Updated learning features such as case studies, key points and Suggested Further Reading are included throughout the text. Textbook of Pharmacoepidemiology is a practical educational resource for upper-level undergraduates, graduate students, post-doctoral fellows in schools of public health, pharmacy and medicine, and for everyone learning and working in pharmacoepidemiology.

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions.Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally.From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.

Pharmacogenomics is the basis of personalized medicine which will be the medicine of the future. Through both reducing the numbers of adverse drug reactions and improving the use of existing drugs in targeted populations, pharmacogenomics represents a real advance on traditional therapeutic drug monitoring. Pharmacogenomics in Clinical Therapeutics provides an introduction to the principles of pharmacogenomics before addressing the pharmacogenomic aspects of key therapeutic areas such as warfarin therapy, cancer chemotherapy, therapy with immunosuppressants, antiretroviral therapy, and psychoactive drugs. It also includes methods of pharmacogenomic testing and the pharmacogenomic aspects of drug–drug interactions. From a team of expert contributors, Pharmacogenomics in Clinical Therapeutics is a comprehensive overview of the current state of pharmacogenomics in pharmacotherapy for all clinicians, pharmacologists and clinical laboratory professionals. It is also a guide for practicing clinicians and health care professionals to the basic principles of pharmacogenomics, laboratory tests currently available to aid clinicians, and the future promise of this developing field.

The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens'Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions'This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS'...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource...'- from a review in The Pharmaceutical Journal

Microneedles can be used for delivery of a wide range of drug substances for practically any medical condition and present a real opportunity for vaccines and medicines that are unsuitable for oral administration or conventional patch delivery. Microneedle-mediated Transdermal and Intradermal Drug Delivery covers the major aspects relating to the use of microneedle arrays in enhancing drug delivery applications. It provides an overview of the various methods employed to design and produce microneedles, from the different materials involved to the importance of application methods. It carefully and critically reviews ongoing transdermal and intradermal delivery research using microneedles and includes the outcomes of in vivo animal and human studies. Importantly, it also discusses the safety and patient acceptability studies carried out to date. Finally, the book reviews the recent patents in microneedle research and describes the ongoing developments within industry that will determine the future of microneedle-mediated transdermal and intradermal drug delivery. By an expert author team with practical experience in the design and development of drug delivery systems this is the only text that provides a comprehensive review of microneedle research in transdermal and intradermal drug delivery.

This book fulfils an urgent need for an updated text on pediatric psychopharmacology. It takes a unique approach in discussing recent findings within the context of current issues, including economic and political ones. The book covers the emerging question of treating children who do not yet meet diagnostic criteria for psychosis, e.g, schizophrenia or bipolar disorder, but who are deemed to be at high risk. This is an active area of debate: such children are being treated in certain centers, while others reject this completely. The book addresses the antidepressant controversy, the placebo response and unique strategies for delineating this, and ways to optimize the differential between active medication and placebo. It reviews the impact of recent American Heart Association guidelines for monitoring children on stimulants and other psychotropics. It adheres closely to DSM-IV diagnostic criteria throughout. The book describes the use of newly approved drugs such as Lexapro for treating adolescent depression and the novel compound Intuniv. It covers the TADS and CAMS studies, which evaluated the use of SSRIs alone and in combination with cognitive behavioral therapy for adolescent depression. Other topics include treatment of bipolar disorders, the increasing popularity of generic equivalents, combination pharmacotherapy and the potential dangers of psychotropic medications. Third edition of the first ever book published on pediatric psychopharmacology from renowned editors. Incorporates current developments with regard to SSRIs, their indications and their safety issues, including possible associated suicidal behavior. Addresses concerns about cardiovascular side effects of the new stimulant medications available, and compares to other FDA-approved medications for ADHD. Features many tables, figures and pictorials, making it highly accessible and reader friendly.

Widely recognised as the best starting point for pharmacology study, the internationally best-selling Medical Pharmacology at a Glance is an ideal companion for all students of the health sciences. Key principles are supported by coloured schematic diagrams - invaluable as both an introduction to medical pharmacology, and revision in the run-up to pharmacology exams. Revised and thoroughly updated throughout, and reflecting changes to the content and assessment methods used by medical schools, Medical Pharmacology at a Glance: Introduces the basic principles of drug action, interaction, absorption and excretion Bases chapters on diseases and syndromes, for clinically-focused learning Includes references to the pathophysiology of disease, to aid understanding of drug choice and action Indicates the therapeutics of choice for specific disorders and conditions Features cross references between discussion of drug classes and diseases Includes self-assessment cases studies with full answers, for revision and review Features a new chapter on immunosuppressants and antirheumatoid drugs Now includes a brand new companion website, with cases and fully downloadable flashcards, at www.ataglanceseries.com/pharmacology

Lecture Notes: Clinical Pharmacology and Therapeutics provides all the necessary information, within one short volume, to achieve a thorough understanding of how drugs work, their interaction with the body in health and disease, and the practical aspects of prescribing drugs appropriately in clinical situations. Presented in an easy-to-use format, this eighth edition builds on the clinical relevance for which the title has become well-known, and features an up-to-date review of drug use across all major clinical disciplines, together with an overview of contemporary medicines regulation and drug development. Key features include: A section devoted to the practical aspects of prescribing Clinical scenarios and accompanying questions to contextualise information End-of-chapter summary boxes Numerous figures and tables which help distil the information for revision purposes Whether you need to develop or refresh your knowledge of pharmacology, Lecture Notes: Clinical Pharmacology and Therapeutics presents'need to know'information for all those involved in prescribing.

This pocket reference guide is a must for all medical students and junior doctors preparing for exams in pharmacology or needing a rapid reminder during a clinical attachment. In light of the growing pressures on those who prescribe drugs to patients, increasing emphasis has been placed on the importance of pharmacology in the undergraduate medical curriculum. Rapid Clinical Pharmacology, with its concise, easy-to-use approach, offers an appealing format for students to use in both clinical practice and exam preparation and its ‘one-page per drug/class'layout easily facilitates the generation of a personal student formulary. Each chapter of the book mirrors each section of the BNF to allow easy cross-referencing and then each chapter is divided into consistent sections as per other books in the Rapid series. Rapid Clinical Pharmacology will also be available as a mobile application for iPhone, iPod Touch, iPad and Blackberry. See wiley.com/go/mededapps for further details.

Covering the latest advances in CNS drug development, this book will guide all those involved in pre-clinical to early clinical trials. The authors describe how recent innovations can accelerate the development of novel CNS compounds, improve early detection of efficacy and toxicity signals, and increase the safety of later-stage clinical trials. The current crisis in the drug development industry is critically reviewed, as well as the steps needed to correct the problems, including new government-backed regulations and industry-based innovations designed to accelerate CNS drug development in the future. Animal-based models of major CNS disorders are described in detail, and the ability of the latest in vitro and computer-based models to simulate CNS disease states and predict drug efficacy and side-effects are examined. Particular attention is given to the growing use of biomarkers and how they can be used effectively in early human trials as signals of potential drug efficacy, as well as the increasingly important role of imaging studies to guide dose selection. Cognitive assessments that can be useful indicators of effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drug trials for over 20 years, and based on a wealth of drug development and clinical trial experience, Critical Pathways to Success in CNS Drug Developmentis full of practical advice for successfully designing and executing CNS drug trials, avoiding potential pitfalls, and complying with government regulations

'The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity.'—Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical'nuts and bolts'approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students.

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

Addressing parasitic diseases and those caused by bacteria, this much needed reference and handbook provides a unique insight into the approach adopted by commercial science towards infectious diseases, including the work of medicinal chemists. Many of the authors are scientists with hands-on experience of drug discovery units within the pharmaceutical industry. In addition, the text covers efforts towards drug development in infectious diseases from academic groups and non profit organizations.

This book is the first to address the most urgent issues, combining a solid basic research approach with applied individual and stress issues, including interventions. Throughout, the focus is on our latest knowledge about various causes of stress and its neuro-cognitive and biological implications. World-renowned authors from Europe as well as the US describe how stress affects the brain of young people as well as adults. They cover the topic from all perspectives, showing how stress affects life in general, from the societal and organizational level to the individual, organ and molecular level. While the book clearly points out stress as a risk factor to health, it also offers a number of evidence-based methods to cope with stress and even ride the positive energy of stress - both as an individual, as well as what managers can do to create a healthy and productive workplace. Written in a reader-friendly and appealing style, the book provides real-life examples from various laboratories, as well as such events as the Volvo Ocean Race, the largest around-the-globe sailing competition. Essential reading for clinicians and biologists, as well as for a wide range of students, including medicine and public health, but also managers and HR staff. With a Foreword by Nobel Laureate Professor Arvid Carlsson (Medicine 2000).

This new edition is an updated practical book for junior doctors and medical students making the transition from medical school to life on the wards. This book presents information on 127 drugs, which junior doctors and students are most likely to encounter on hospital wards or during their course of study. The hands-on guide to clinical pharmacology 2nd edition includes sections containing both treatment regimens of common conditions and detailed information on the relevant drugs that will help you obtain a better understanding of therapeutic management. Written to provide a study aid or as a user friendly reference on the wards, the book gives you: An essential learning tool for clinical pharmacology A system based approach A-Z of 127 key drugs in a one-drug-per-page format Important interactions, adverse effects and contraindications A fully indexed text A quick reference, pocket-sized reassurance This book will help take the stress out of clinical pharmacology and pharmacology exams!

Symptoms in the Pharmacy presents a guide to the management of common symptoms seen in the pharmacy, with advice from an author team that includes both pharmacists and GPs. With the continued emphasis on the pharmacist's role as a'first port of call'in response to symptoms, the need for effective communication and interpersonal skills remains paramount. This book provides the pharmacist with the appropriate techniques for gathering information to meet the needs of patient safety in a way that is acceptable to the public. Case studies and comments from the pharmacist's and doctor's perspective are included throughout. This is now the fifth edition of Symptoms in the Pharmacy. The text has been fully revised to reflect the latest'prescription only medicine'to'pharmacy medicine'switches. Changes in medicine use, cautions and contraindications where recent evidence has shown new safety concerns are also covered. Similarly, where new evidence has shown treatments to be less effective and thus superseded, they have been removed. Reviewer: A reader from Bradford UK This book is an excellent guide for either trainee or newly qualified pharmacists. It covers most ailments which may be encountered on a daily basis in the community pharmacy and describes features of more serious underlying disease to aid diagnosis or referral. It is well presented and clearly laid out with separate chapters for each ailment. At the end of each chapter are example case studies giving in summary both the view of a pharmacist and medical doctor for each condition. My only criticism is that there are no illustrations or diagrams which I feel would have been helpful when describing clinical features of some conditions. Nonetheless there are clear descriptions of each ailment, highlighting symptoms, possible causes and most appropriate treatments. Importantly it gives clear guidelines on when to refer presenting ailments to a doctor. It is comparable in style to the title Minor Illness or Major Disease, however this title is illustrated with photographs of illness to aid recognition. A useful guide for all student pharmacists, preregistration pharmacists and possibly newly qualified pharmacists.

Completely revised and updated Pharmaceutical Microbiology continues to provide the essential resource for the 21st century pharmaceutical microbiologist'...a valuable resource for junior pharmacists grasping an appreciation of microbiology, microbiologists entering the pharmaceutical field, and undergraduate pharmacy students.'Journal of Antimicrobial Chemotherapy'...highly readable. The content is comprehensive, with well-produced tables, diagrams and photographs, and is accessible through the extensive index.'Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace of change in the teaching and practice of pharmaceutical microbiology Expanded coverage of modern biotechnology, including genomics and recombinant DNA technology Updated information on newer antimicrobial agents and their mode of action Highly illustrated with structural formulas of organic compounds and flow diagrams of biochemical processes

The hands-on guide to practical prescribing is a concise, easy-to-use guide to the practical aspects of pharmacology for junior doctors who are making the transition from studying pharmacology to prescribing drugs for the first time. This new addition to'The hands-on guide'series brings together the core pharmacological knowledge required by house officers, structured in a way to address the very hands-on, practical aspects of prescribing. This book is not designed to replace the factual drug information in the BNF, but to complement and build upon it, so that The hands-on guide to practical prescribing provides junior doctors with a solid guide to prescribing in the clinical setting. Beginning with the general principles of prescribing and basics of writing a prescription form, the book guides you through topics such as using the BNF, drug interactions and monitoring toxicity, before moving on to cover both surgical and medical topics such as preoperative and postoperative patients, prophylaxis, organ failure and diabetes. The hands-on guide to practical prescribing is a problem-based book that covers the common problems and questions a house officer might encounter, and will be an invaluable guide to life on the wards. The authors are specialist registrars in medicine and surgery, have undertaken SHO and registrar posts in the major specialities and also write and teach regularly on clinical pharmacology.

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with'newer'pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Proposed changes in practice legislation will allow podiatrists to prescribe a limited range of drugs and dressings. It is therefore now imperative that students and practitioners understand pharmacology. Not only the mechanisms of action of drugs, but also their potential side-effects and interactions with other drugs taken by the patient. This book will cover both basic and clinical pharmacology. The podiatrist's role in examination, assessment and diagnosis are considered.

Since the development of the NMR spectrometer in the 1950s, NMR spectra have been widely used for the elucidation of the 2D structure of newly synthesized and natural compounds. In the 1980s, the high-resolution NMR spectrometer (> 300 Mhz) and 2D experiments were introduced, which opens up the possibility to determine the 3D structure of large molecules, especially biomolecules. However, NMR spectroscopy has been rarely applied to drug analysis. This book illustrates the power and versatility of NMR spectroscopy in the determination of impurities in and the content of drugs, the composition of polymer excipients, the characterization of isomeric drug mixtures, the complexity of drugs with small-size components or ions, and the behavior of drugs in acid and basic solution. In addition, NMR spectroscopy and especially the hyphenated technique with HPLC is shown to be a powerful tool to measure a drug and its metabolites in various body fluids. The solid state NMR technique can give information on the structure, especially the conformation of drugs and excipients in drug formulations. Recently, SAR by NMR, introduced by Fesik, impressively demonstrated the potential of NMR spectroscopy in drug development and in the characterization of the interaction between large molecules and ligands. The complexation between proteins, lipids and cyclodextrins with drugs is described. Finally, NMR imaging (MRI and MRS) can be used to characterize the liberation of drugs from a drug formulation. Furthermore, the distribution of substances in plants, in animals, in tissues and in humans can be visualized by imaging. In short, this book covers all aspects of drug analysis.