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Preface | ||
About the Author | ||
Ch. 1 | Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals | 1 |
Ch. 2 | Regulation of Human Pharmaceutical Safety | 30 |
Ch. 3 | Information Sources: Building and Maintaining Data Files | 99 |
Ch. 4 | Screens in Safety and Hazard Assessment | 112 |
Ch. 5 | Acute Toxicity Testing in Drug Safety Evaluation | 130 |
Ch. 6 | Genotoxicity | 176 |
Ch. 7 | Subchronic and Chronic Toxicity Studies | 237 |
Ch. 8 | Developmental and Reproductive Toxicity Testing | 258 |
Ch. 9 | Carcinogenicity Studies | 297 |
Ch. 10 | Safety Assessment of Inhalant Drugs | 335 |
Ch. 11 | Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment | 367 |
Ch. 12 | Special Concerns for the Preclinical Evaluation of Biotechnology Products | 404 |
Ch. 13 | Formulations, Routes, and Dosage Designs | 442 |
Ch. 14 | Occupational Toxicology in the Pharmaceutical Industry | 505 |
Ch. 15 | Immunotoxicology in Pharmaceutical Development | 527 |
Ch. 16 | Large Animal Studies | 595 |
Ch. 17 | The Application of In Vitro Techniques in Drug Safety Assessment | 634 |
Ch. 18 | Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation | 691 |
Ch. 19 | Safety Pharmacology | 737 |
Ch. 20 | Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond | 764 |
Ch. 21 | Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs) | 831 |
Ch. 22 | Statistics in Pharmaceutical Safety Assessment | 862 |
App. A | Selected Regulatory and Toxicological Acronyms | 971 |
App. B | Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies | 975 |
App. C | Notable Regulatory Internet Addresses | 979 |
App. D | Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents | 990 |
Index | 997 |
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