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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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Add Drug Safety Evaluation, Drug Safety Evaluation Second Edition Shayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are respo, Drug Safety Evaluation to the inventory that you are selling on WonderClubX
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Add Drug Safety Evaluation, Drug Safety Evaluation Second Edition Shayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are respo, Drug Safety Evaluation to your collection on WonderClub |