Drugs: From Discovery to Approval

摘要: PREFACE. 1 INTRODUCTION. 1.1 Aim of This Book. 1.2 An Overview the Drug Discovery and Development Process. 1.3 The Pharmaceutical Industry. 1.4 Economics Development. 1.5 Trends in 1.6 Case Study #1. 1.7 Summary Important Points. 1.8 Review Questions. 1.9 Brief Answers Explanations. 1.10 Further Reading. 2 DRUG DISCOVERY: TARGETS AND RECEPTORS. 2.1 Processes. 2.2 Medical Needs. 2.3 Target Identifi cation. 2.4 Validation. 2.5 Interactions with Targets or Receptors. 2.6 Enzymes. 2.7 Receptors Signal Transduction. 2.8 Assay 2.9 #2. 2.10 2.11 2.12 2.13 3 SMALL MOLECULE DRUGS. 3.1 Introduction. 3.2 Irrational Approach. 3.3 Rational 3.4 Antisense 3.5 RNA Interference 3.6 Chiral Drugs. 3.7 Closing Remarks. 3.8 #3. 3.9 3.10 3.11 3.12 4 LARGE 4.1 4.2 Vaccines. 4.3 Antibodies. 4.4 Cytokines. 4.5 Hormones. 4.6 Gene Therapy. 4.7 Stem Cells Cell 4.8 #4. 4.9 4.10 4.11 4.12 5 DEVELOPMENT PRECLINICAL STUDIES. 5.1 5.2 Pharmacodynamics. 5.3 Pharmacokinetics. 5.4 Toxicology. 5.5 Animal Tests, In Vitro Assays, Silico Methods. 5.6 Formulations Delivery Systems. 5.7 Nanotechnology. 5.8 #5. 5.9 5.10 5.11 5.12 6 CLINICAL TRIALS. 6.1 Defi nition Clinical Trial. 6.2 Ethical Considerations. 6.3 Trials. 6.4 Regulatory Requirements for 6.5 Role Authorities. 6.6 Therapy 6.7 #6. 6.8 6.9 6.10 6.11 7 REGULATORY AUTHORITIES. 7.1 7.2 US Food Administration. 7.3 European Medicines Agency. 7.4 Japan's Ministry Health, Labor Welfare. 7.5 China's State 7.6 India's Central Drugs Standard Control Organization. 7.7 Australia's Therapeutics Goods 7.8 Canada's Health Canada. 7.9 Other 7.10 Authorities than Agencies. 7.11 International Conference on Harmonization. 7.12 World 7.13 Inspection Cooperation Scheme. 7.14 #7. 7.15 7.16 7.17 7.18 8 APPLICATIONS. 8.1 8.2 8.3 Union. 8.4 Japan. 8.5 China. 8.6 India. 8.7 Australia. 8.8 8.9 #8. 8.10 8.11 8.12 8.13 9 GOOD MANUFACTURING PRACTICE: REQUIREMENT. 9.1 9.2 United States. 9.3 Europe. 9.4 9.5 Core Elements GMP. 9.6 Selected GMP 9.7 FDA's New cGMP Initiative. 9.8 #9. 9.9 9.10 9.11 9.12 10 MANUFACTURING. 10.1 10.2 Manufacturing. 10.3 Inspection. 10.4 Manufacture Small Molecule APIs (Chemical Synthesis Methods). 10.5 Large (Recombirant DNA 10.6 Finished Dosage Forms. 11 FUTURE PERSPECTIVES. 11.1 Past Advances Future Challenges. 11.2 11.3 Biopharmaceutical 11.4 Traditional Medicine. 11.5 Individualized APPENDIX HISTORY OF DISCOVERY DEVELOPMENT. A1.1 Early History A1.2 Middle Ages. A1.3 Foundation Current A1.4 Beginnings Modern A1.5 Evolution Products. A1.6 CELLS, NUCLEIC ACIDS, GENES, PROTEINS. A2.1 Cells. A2.2 Nucleic Acids. A2.3 Genes Proteins. A2.4 SELECTED DRUGS THEIR MECHANISMS ACTION. A DHFR PLASMID VECTOR. VACCINE PRODUCTION METHODS. PHARMACOLOGY/ TOXICOLOGY. REVIEW FORMAT. EXAMPLES GENERAL BIOMARKERS. TOXICITY GRADING. HEALTH SYSTEMS IN COUNTRIES. ACRONYMS. GLOSSARY. INDEX.