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Drugs: From Discovery to Approval

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The new edition of this bestselling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large ...
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Overview

The new edition of this bestselling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.
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Editorial Reviews

From the Publisher
"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs." (Doody's Reviews, May 2009)

"This textbook provides the reader with a high-level overview of the drug discovery process and the regulatory challenges facing the journey from drug molecule to marketplace." (The Pharmaceutical Journal, March 2009)

"The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials." (Chemistry World, February 2009)

Doody's Review Service
Reviewer: Michael R Jacobs, BS, PharmD (Temple University School of Pharmacy)
Description: This is the second edition of a book, first published in 2004, that provides an overview of how drugs are discovered and the path that a compound takes on its way to final approval for human use. Each chapter contains a case study, review questions and answers, and a summary of important points. The book includes a number of "exhibits" designed to expand and clarify specific issues to assist readers by providing a context or application for the information in certain sections. The exhibits vary substantially in meeting this goal. Also included are nine appendixes, a list of acronyms, a glossary, and an index.
Purpose: While the objective of providing an overview of the drug approval process is worthy, it is also a monumental undertaking. The breadth of topics covered is substantial and includes the basics of drug-receptor interactions, small and large molecule drug discovery, preclinical testing, clinical trials, regulatory issues, and good manufacturing practices. Volumes have been written on each of these topics; consequently the depth to which they are covered in this book is limited. Even so, the author has provided the promised overview.
Audience: The book is intended for academic and industry researchers and healthcare policy makers, as well as students in the health professions. It may be most useful for individuals unfamiliar with the complexities of the drug development process and those who may work in the pharmaceutical industry who would like to understand the challenges outside of their own area of expertise. The author has over 25 years of experience in the pharmaceutical industry in managerial positions.
Features: The book lays the groundwork with the basics of drug-receptor interactions and brief discussions of potential drug targets such as various enzymes. Thereafter, animal studies and other preclinical testing are described, followed by a review of the various phases of human trials. Regulatory authorities (i.e. the ministries and agencies that regulate drug development) and regulatory applications (how drugs are approved) are addressed in two separate chapters and might have been combined. The information provided about regulatory authorities is somewhat unbalanced, with nearly four pages devoted to the U.S. FDA while the Canadian system, Health Canada, is covered in a single paragraph. The glossary has fewer than 100 entries and it is unclear why some were selected for inclusion (such as otitis media and re-stenosis), which have little to do with the general drug discovery process itself. The nine appendixes vary considerably in their relevance to the drug development process. For example, one appendix contains 27 "selected" drugs, their class, and mechanisms of action. In this section, antagonist and blocker are used interchangeably, and the mechanisms of action are not always very descriptive ("diazepam acts as a central nervous system depressant"). Furthermore, some of the information is duplicated in Table 2.4. The general biomarkers appendix lists common laboratory tests, which does not reflect the current use of this phrase, and the acronyms do not always relate to drug development (e.g. TM = traditional medicine and IOC = International Olympic Committee). The book contains more misspellings than I am accustomed to seeing, inconsistencies in the information presented (figures depicting drug movement through the body), oversimplification of some concepts (time-concentration curves), and some misinformation (albuterol described as a beta-2 antagonist).
Assessment: The author took on a substantial challenge in writing this book. Several books would be required to cover the breadth of material available here. However, it does serve the purpose of revealing to those outside of the pharmaceutical industry the complexities of bringing a drug to market. Those more familiar with drug development may find only certain chapters outside of their area of expertise to be useful. Rapid changes in drug development technology support the need for a second edition.
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Product Details

  • ISBN-13: 9780471601500
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 1/9/2004
  • Edition description: Older Edition
  • Edition number: 1
  • Pages: 368
  • Product dimensions: 6.46 (w) x 9.41 (h) x 0.91 (d)

Meet the Author

Rick Ng, PhD, has worked for more than twenty-five years in senior management positions in the private sector pharmaceutical industry. He is currently a director at a biopharmaceutical manufacturing facility in Singapore. He has provided technical training for graduate and postgraduate personnel.

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Table of Contents

Preface
Ch. 1 Introduction 1
Ch. 2 Drug Discovery: Targets and Receptors 15
Ch. 3 Drug Discovery: Small Molecule Drugs 43
Ch. 4 Drug Discovery: Large Molecule Drugs 75
Ch. 5 Drug Development and Preclinical Studies 107
Ch. 6 Clinical Trial 139
Ch. 7 Regulatory Authorities 159
Ch. 8 Regulatory Applications 175
Ch. 9 Good Manufacturing Practice: Regulatory Requirements 211
Ch. 10 Good Manufacturing Practice: Drug Manufacturing 247
Ch. 11 Future Perspectives 281
App. 1 History of Drug Discovery and Development 305
App. 2 Cells, Nucleic Acids, Genes and Proteins 313
App. 3 Selected Drugs and Their Mechanisms of Action 327
App. 4 Pharmacology/Toxicology Review Format 329
Acronyms 335
Glossary 339
Index 347
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