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This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boastscomplete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide tothe global industry and this volume provides a complete update.

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.Features: Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material

In an increasingly complex and sophisticated marketplace, businesses are spending more on consulting services than ever before. Keep up with this healthy, growing and dynamic segment of the U.S. and Canadian economies with Consultants & Consulting Organizations Directory. You'll find complete contact information as well as full, clear, and concise descriptions of each organization's activities. More than 26,000 firms and individuals listed are arranged in subject sections under 14 general fields of consulting activity, ranging from agriculture to marketing. More than 400 specialties are represented, including finance, computers, fund-raising, and others.

In an increasingly complex and sophisticated marketplace, businesses are spending more on consulting services than ever before. Keep up with this healthy, growing and dynamic segment of the U.S. and Canadian economies with Consultants & Consulting Organizations Directory. You'll find complete contact information as well as full, clear, and concise descriptions of each organization's activities. More than 26,000 firms and individuals listed are arranged in subject sections under 14 general fields of consulting activity, ranging from agriculture to marketing. More than 400 specialties are represented, including finance, computers, fund-raising, and others.

With the rapidly growing importance of sustainability and corporate responsibility in a globalised world, management schools are increasingly integrating long-term economic, environmental and social issues into their teaching and research. Climate change, poverty, labour standards and human rights are among the many topics that future decision-makers will need to face in their careers. Business education needs to reflect this new reality and provide a broadened understanding of value creation in order to create economic capital while developing social and preserving natural capital.Case studies can be important tools for creating learning processes on different levels - students are forced to struggle with exactly the kinds of decisions and dilemmas managers confront every day. In this reflection of reality, the values and goals of the student are systematically challenged. This can be especially valuable in the context of sustainability management - organisations are now continually forced to value the different aspects of sustainability and their interrelations: How do social issues impact the economic bottom line? How can an environmentally sound strategy create a positive impact on employee motivation and thus have measurable impact on economic performance? What comes first and why?This third collection of oikos case studies is based on the winning cases from the 2010 to 2013 annual case competition. So what makes an excellent case in sustainability management? These cases have been highly praised because they provide excellent learning opportunities, tell engaging stories, deal with recent situations, include quotations from key actors, are thought-provoking and controversial, require decision-making and provide clear take-aways. These cases are clustered in three different sections:'Large Corporations and Corporate Sustainability Dilemmas','Managing Stakeholder Relations'and'Sustainability as a Source of Differentiation Strategies'.Case Studies in Sustainability Management will be an essential purchase for educators and is likely to be a widely used as a course textbook at all levels of management education.Online Teaching Notes to accompany each chapter are available on request with the purchase of the book.