Drugs: From Discovery to Approval / Edition 2

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Overview

"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

"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

The new edition of this best-selling 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 pre-clinical 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.

This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.

Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

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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: 9780470195109
  • Publisher: Wiley
  • Publication date: 11/24/2008
  • Edition description: New Edition
  • Edition number: 2
  • Pages: 480
  • Sales rank: 199,060
  • Product dimensions: 6.40 (w) x 9.30 (h) x 1.00 (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.

1 INTRODUCTION.

1.1 Aim of This Book.

1.2 An Overview of the Drug Discovery and Development Process.

1.3 The Pharmaceutical Industry.

1.4 Economics of Drug Discovery and Development.

1.5 Trends in Drug Discovery and Development.

1.6 Case Study #1.

1.7 Summary of Important Points.

1.8 Review Questions.

1.9 Brief Answers and Explanations.

1.10 Further Reading.

2 DRUG DISCOVERY: TARGETS AND RECEPTORS.

2.1 Drug Discovery Processes.

2.2 Medical Needs.

2.3 Target Identifi cation.

2.4 Target Validation.

2.5 Drug Interactions with Targets or Receptors.

2.6 Enzymes.

2.7 Receptors and Signal Transduction.

2.8 Assay Development.

2.9 Case Study #2.

2.10 Summary of Important Points.

2.11 Review Questions.

2.12 Brief Answers and Explanations.

2.13 Further Reading.

3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.

3.1 Introduction.

3.2 Irrational Approach.

3.3 Rational Approach.

3.4 Antisense Approach.

3.5 RNA Interference Approach.

3.6 Chiral Drugs.

3.7 Closing Remarks.

3.8 Case Study #3.

3.9 Summary of Important Points.

3.10 Review Questions.

3.11 Brief Answers and Explanations.

3.12 Further Reading.

4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.

4.1 Introduction.

4.2 Vaccines.

4.3 Antibodies.

4.4 Cytokines.

4.5 Hormones.

4.6 Gene Therapy.

4.7 Stem Cells and Cell Therapy.

4.8 Case Study #4.

4.9 Summary of Important Points.

4.10 Review Questions.

4.11 Brief Answers and Explanations.

4.12 Further Reading.

5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.

5.1 Introduction.

5.2 Pharmacodynamics.

5.3 Pharmacokinetics.

5.4 Toxicology.

5.5 Animal Tests, In Vitro Assays, and In Silico Methods.

5.6 Formulations and Delivery Systems.

5.7 Nanotechnology.

5.8 Case Study #5.

5.9 Summary of Important Points.

5.10 Review Questions.

5.11 Brief Answers and Explanations.

5.12 Further Reading.

6 CLINICAL TRIALS.

6.1 Defi nition of Clinical Trial.

6.2 Ethical Considerations.

6.3 Clinical Trials.

6.4 Regulatory Requirements for Clinical Trials.

6.5 Role of Regulatory Authorities.

6.6 Gene Therapy Clinical Trial.

6.7 Case Study #6.

6.8 Summary of Important Points.

6.9 Review Questions.

6.10 Brief Answers and Explanations.

6.11 Further Reading.

7 REGULATORY AUTHORITIES.

7.1 Role of Regulatory Authorities.

7.2 US Food and Drug Administration.

7.3 European Medicines Agency.

7.4 Japan’s Ministry of Health, Labor and Welfare.

7.5 China’s State Food and Drug Administration.

7.6 India’s Central Drugs Standard Control Organization.

7.7 Australia’s Therapeutics Goods Administration.

7.8 Canada’s Health Canada.

7.9 Other Regulatory Authorities.

7.10 Authorities Other than Drug Regulatory Agencies.

7.11 International Conference on Harmonization.

7.12 World Health Organization.

7.13 Pharmaceutical Inspection Cooperation Scheme.

7.14 Case Study #7.

7.15 Summary of Important Points.

7.16 Review Questions.

7.17 Brief Answers and Explanations.

7.18 Further Reading.

8 REGULATORY APPLICATIONS.

8.1 Introduction.

8.2 Food and Drug Administration.

8.3 European Union.

8.4 Japan.

8.5 China.

8.6 India.

8.7 Australia.

8.8 Canada.

8.9 Case Study #8.

8.10 Summary of Important Points.

8.11 Review Questions.

8.12 Brief Answers and Explanations.

8.13 Further Reading.

9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT.

9.1 Introduction.

9.2 United States.

9.3 Europe.

9.4 International Conference on Harmonization.

9.5 Core Elements of GMP.

9.6 Selected GMP Systems.

9.7 The FDA’s New cGMP Initiative.

9.8 Case Study #9.

9.9 Summary of Important Points.

9.10 Review Questions.

9.11 Brief Answers and Explanations.

9.12 Further Reading.

10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.

10.1 Introduction.

10.2 GMP Manufacturing.

10.3 GMP Inspection.

10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).

10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).

10.6 Finished Dosage Forms.

11 FUTURE PERSPECTIVES.

11.1 Past Advances and Future Challenges.

11.2 Small Molecule Pharmaceutical Drugs.

11.3 Large Molecule Biopharmaceutical Drugs.

11.4 Traditional Medicine.

11.5 Individualized Medicine.

APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.

A1.1 Early History of Medicine.

A1.2 Drug Discovery and Development in the Middle Ages.

A1.3 Foundation of Current Drug Discovery and Development.

A1.4 Beginnings of Modern Pharmaceutical Industry.

A1.5 Evolution of Drug Products.

A1.6 Further Reading.

APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.

A2.1 Cells.

A2.2 Nucleic Acids.

A2.3 Genes and Proteins.

A2.4 Further Reading.

APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.

APPENDIX 4 A DHFR PLASMID VECTOR.

APPENDIX 5 VACCINE PRODUCTION METHODS.

APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.

REVIEW FORMAT.

APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.

APPENDIX 8 TOXICITY GRADING.

APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.

ACRONYMS.

GLOSSARY.

INDEX.

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