Drugs: From Discovery to Approval, 2nd Edition
December 2008, ©2009, Wiley-Blackwell
—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.
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.
2.7 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.
3.2 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.
4.6 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.
5.5 Animal Tests, In Vitro Assays, and In Silico Methods.
5.6 Formulations and Delivery Systems.
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.
8.2 Food and Drug Administration.
8.3 European Union.
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.
9.2 United States.
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.
10.2 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.
A2.2 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.
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.
"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)