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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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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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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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Chiral Drugs | |
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Closing Remarks | |
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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 | |
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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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Further Reading | |
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Clinical Trial | |
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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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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 Agency for the Evaluation of Medicinal Products | |
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Japan's Ministry of Health, Labour and Welfare | |
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China's State Drug Administration | |
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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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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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Further Reading | |
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Good Manufacturing Practice: Regulatory Requirements | |
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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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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 | |
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Manufacture of Large Molecule APIs | |
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Finished Dosage Forms | |
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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 Animal and Plants | |
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Regulatory Issues | |
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Intellectual Property Rights | |
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Concluding Remarks | |
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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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Pharmacology/Toxicology Review Format | |
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Acronyms | |
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Glossary | |
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Index | |