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