Drug Safety Evaluation - Gad, Shayne Cox

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PREFACE xxix ABOUT THE AUTHORS xxxi 1 The Drug Development Process and The Global Pharmaceutical Marketplace 1 2 Regulation of Human Pharmaceutical Safety: Routes To Human Use and Market 19 3 Data Mining: Sources of Information For Consideration In Study And Program Design and In Safety Evaluation 67 4 Electronic Records, Reporting, and Submission: eCTD and Send 75 5 Screens in Safety and Hazard Assessment 83 6 Formulations, Routes, and Dosage Regimens 95 7 Mechanisms And End Points Of Drug Toxicity 131 8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF 143 9 Repeat-Dose Toxicity Studies 173 10 Genotoxicity 183 11 QSAR Tools For Drug Safety 223 12 Toxicogenomics 241 13 Immunotoxicology In Drug Development 247 14 Nonrodent Animal Studies 293 15 Developmental And Reproductive Toxicity Testing 331 16 Carcinogenicity Studies 363 17 Histopathology and Clinical Pathology In Nonclinical Pharmaceutical Safety Assessment 395 18 Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment 403 19 Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation 425 20 Safety Pharmacology 457 21 Special Concerns For The Preclinical Evaluation Of Biotechnology Products 477 22 Safety Assessment of Inhalant Drugs And Dermal Route Drugs 507 23 Special Case Products: Imaging Agents 529 24 Special Case Products: Drugs For Treatment Of Cancer 535 25 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile And Pediatric Toxicology) 543 26 Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology 551 27 Occupational Toxicology In The Pharmaceutical Industry 571 28 Strategy and Phasing For Nonclinical Drug Safety EvaluationIn The Discovery and Development of Pharmaceuticals 585 29 The Application of In Vitro Techniques In Drug Safety Assessment 603 30 Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond 635 31 Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting of Adverse Drug Responses (ADRs) 683 32 Statistics In Pharmaceutical Safety Assessment 707 33 Combination Products: Drugs and Devices 767 34 Qualification Of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals 777 35 Tissue, Cell, and Gene Therapy 789 36 Adverse Outcome Pathways in Drug Safety Assessment 801 Appendix A: Selected Regulatory and Toxicological Acronyms 805 Appendix B: Definition Of Terms And Lexicon of Clinical Observations in Nonclinical (Animal) Studies 807 Appendix C: Notable Regulatory Internet Addresses 811 Appendix D: Glossary Of Terms Used in The Clinical Evaluation of Therapeutic Agents 817 Appendix E: Common Vehicles For The Nonclinical Evaluation of Therapeutic Agents 821 Appendix F: Global Directory of Contract Toxicology Labs 919 INDEX 945