| |
| |
Preface | |
| |
| |
| |
Introduction | |
| |
| |
| |
Aim of This Book | |
| |
| |
| |
An Overview of the Drug Discovery and Development Process | |
| |
| |
| |
The Pharmaceutical Industry | |
| |
| |
| |
Economics of Drug Discovery and Development | |
| |
| |
| |
Trends in Drug Discovery and Development | |
| |
| |
| |
Case Study #1 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Drug Discovery: Targets and Receptors | |
| |
| |
| |
Drug Discovery Processes | |
| |
| |
| |
Medical Needs | |
| |
| |
| |
Target Identification | |
| |
| |
| |
Target Validation | |
| |
| |
| |
Drug Interactions with Targets or Receptors | |
| |
| |
| |
Enzymes | |
| |
| |
| |
Receptors and Signal Transduction | |
| |
| |
| |
Assay Development | |
| |
| |
| |
Case Study #2 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Drug Discovery: Small Molecule Drugs | |
| |
| |
| |
Introduction | |
| |
| |
| |
Irrational Approach | |
| |
| |
| |
Rational Approach | |
| |
| |
| |
Antisense Approach | |
| |
| |
| |
RNA Interference Approach | |
| |
| |
| |
Chiral Drugs | |
| |
| |
| |
Closing Remarks | |
| |
| |
| |
Case Study #3 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Drug Discovery: Large Molecule Drugs | |
| |
| |
| |
Introduction | |
| |
| |
| |
Vaccines | |
| |
| |
| |
Antibodies | |
| |
| |
| |
Cytokines | |
| |
| |
| |
Hormones | |
| |
| |
| |
Gene Therapy | |
| |
| |
| |
Stem Cells and Cell Therapy | |
| |
| |
| |
Case Study #4 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Drug Development and Preclinical Studies | |
| |
| |
| |
Introduction | |
| |
| |
| |
Pharmacodynamics | |
| |
| |
| |
Pharmacokinetics | |
| |
| |
| |
Toxicology | |
| |
| |
| |
Animal Tests, In Vitro Assays, and In Silico Methods | |
| |
| |
| |
Formulations and Delivery Systems | |
| |
| |
| |
Nanotechnology | |
| |
| |
| |
Case Study #5 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Clinical Trials | |
| |
| |
| |
Definition of Clinical Trial | |
| |
| |
| |
Ethical Considerations | |
| |
| |
| |
Clinical Trials | |
| |
| |
| |
Regulatory Requirements for Clinical Trials | |
| |
| |
| |
Role of Regulatory Authorities | |
| |
| |
| |
Gene Therapy Clinical Trial | |
| |
| |
| |
Case Study #6 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Regulatory Authorities | |
| |
| |
| |
Role of Regulatory Authorities | |
| |
| |
| |
US Food and Drug Administration | |
| |
| |
| |
European Medicines Agency | |
| |
| |
| |
Japan's Ministry of Health, Labor and Welfare | |
| |
| |
| |
China's State Food and Drug Administration | |
| |
| |
| |
India's Central Drugs Standard Control Organization | |
| |
| |
| |
Australia's Therapeutics Goods Administration | |
| |
| |
| |
Canada's Health Canada | |
| |
| |
| |
Other Regulatory Authorities | |
| |
| |
| |
Authorities Other than Drug Regulatory Agencies | |
| |
| |
| |
International Conference on Harmonization | |
| |
| |
| |
World Health Organization | |
| |
| |
| |
Pharmaceutical Inspection Cooperation Scheme | |
| |
| |
| |
Case Study #7 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Regulatory Applications | |
| |
| |
| |
Introduction | |
| |
| |
| |
Food and Drug Administration | |
| |
| |
| |
European Union | |
| |
| |
| |
Japan | |
| |
| |
| |
China | |
| |
| |
| |
India | |
| |
| |
| |
Australia | |
| |
| |
| |
Canada | |
| |
| |
| |
Case Study #8 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Good Manufacturing Practice: Regulatory Requirement | |
| |
| |
| |
Introduction | |
| |
| |
| |
United States | |
| |
| |
| |
Europe | |
| |
| |
| |
International Conference on Harmonization | |
| |
| |
| |
Core Elements of GMP | |
| |
| |
| |
Selected GMP Systems | |
| |
| |
| |
The FDA's New cGMP Initiative | |
| |
| |
| |
Case Study #9 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Good Manufacturing Practice: Drug Manufacturing | |
| |
| |
| |
Introduction | |
| |
| |
| |
GMP Manufacturing | |
| |
| |
| |
GMP Inspection | |
| |
| |
| |
Manufacture of Small Molecule APIs (Chemical Synthesis Methods) | |
| |
| |
| |
Manufacture of Large Molecule APIs (Recombirant DNA Methods) | |
| |
| |
| |
Finished Dosage Forms | |
| |
| |
| |
Case Study #10 | |
| |
| |
| |
Summary of Important Points | |
| |
| |
| |
Review Questions | |
| |
| |
| |
Brief Answers and Explanations | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Future Perspectives | |
| |
| |
| |
Past Advances and Future Challenges | |
| |
| |
| |
Small Molecule Pharmaceutical Drugs | |
| |
| |
| |
Large Molecule Biopharmaceutical Drugs | |
| |
| |
| |
Traditional Medicine | |
| |
| |
| |
Individualized Medicine | |
| |
| |
| |
Gene Therapy | |
| |
| |
| |
Cloning and Stem Cells | |
| |
| |
| |
Old Age Diseases and Aging | |
| |
| |
| |
Lifestyle Drugs | |
| |
| |
| |
Performance-Enhancing Drugs | |
| |
| |
| |
Chemical and Biological Terrorism | |
| |
| |
| |
Transgenic Animals and Plants | |
| |
| |
| |
Antimicrobial Drug Resistance | |
| |
| |
| |
Regulatory Issues | |
| |
| |
| |
Intellectual Property Rights | |
| |
| |
| |
Bioethics | |
| |
| |
| |
Concluding Remarks | |
| |
| |
| |
Case Study #11 | |
| |
| |
| |
Further Reading | |
| |
| |
| |
History of Drug Discovery and Development | |
| |
| |
| |
Early History of Medicine | |
| |
| |
| |
Drug Discovery and Development in the Middle Ages | |
| |
| |
| |
Foundation of Current Drug Discovery and Development | |
| |
| |
| |
Beginnings of Modern Pharmaceutical Industry | |
| |
| |
| |
Evolution of Drug Products | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Cells, Nucleic Acids, Genes, and Proteins | |
| |
| |
| |
Cells | |
| |
| |
| |
Nucleic Acids | |
| |
| |
| |
Genes and Proteins | |
| |
| |
| |
Further Reading | |
| |
| |
| |
Selected Drugs and Their Mechanisms of Action | |
| |
| |
| |
A DHFR Plasmid Vector | |
| |
| |
| |
Vaccine Production Methods | |
| |
| |
| |
Pharmacology/Toxicology Review Format | |
| |
| |
| |
Examples of General Biomarkers | |
| |
| |
| |
Toxicity Grading | |
| |
| |
| |
Health Systems in Selected Countries | |
| |
| |
Acronyms | |
| |
| |
Glossary | |
| |
| |
Index | |