Drug Safety Evaluation

COVER......Page 1
fmatter......Page 2
Contents......Page 7
Ch1-the-drug-development-process-and-the-global-pharmaceutical-marketplace......Page 27
Ch2-regulation-of-human-pharmaceutical-safety......Page 39
Ch3-data-mining......Page 85
Ch4-screens-in-safety-and-hazard-assessment......Page 93
Ch5-formulations-routes-and-dosage-regimens......Page 104
Ch6-nonclinical-manifestations-mechanisms-and-end-points-of-drug-tox......Page 139
Ch7-pilot-toxicity-testing-in-drug-safety-evaluation......Page 152
Ch8-repeatdose-toxicity-studies......Page 182
Ch9-genotoxicity......Page 191
Ch10-qsar-tools-for-drug-safety......Page 230
Ch11-immunotoxicology-in-drug-development......Page 246
Ch12-nonrodent-animal-studies......Page 290
Ch13-developmental-and-reproductive-toxicity-testing......Page 312
Ch14-carcinogenicity-studies......Page 342
Ch15-histopathology-in-nonclinical-pharmaceutical-safety-assessment......Page 372
Ch16-irritation-and-local-tissue-tolerance-in-pharmaceutical-safety-assessment......Page 379
Ch17-pharmacokinetics-and-toxicokinetics-in-drug-safety-evaluation......Page 400
Ch18-safety-pharmacology......Page 431
Ch19-special-concerns-for-the-preclinical-evaluation-of-biotechnology......Page 451
Ch20-safety-assessment-of-inhalant-drugs-and-dermal-route-drugs......Page 479
Ch21-special-case-products-imaging agents......Page 500
Ch22-special-case-products-drugs-fot-treatment-of-cancer......Page 505
Ch23-pediatric-product-safety-assessment-2006-guidance-including-juvenile toxicology......Page 510
Ch24-use-of-imaging-imaging-agents-and-radiopharmaceuticals-in-nonclinical-toxicology......Page 518
Ch25-occupational-toxicology-in-the-pharmaceutical-industry......Page 537
Ch26-strategy-and-phasing-for-nonclinical-drug-safety-evaluation-in-the-discovery-and-development-of-pharmaceuticals......Page 550
Ch27-the-application-of-in-vitro-techniques-in-drug-safety-assessment......Page 566
Ch28-evaluation-of-human-tolerance-and-safety-in-clinical-trials......Page 596
Ch29-postmarketing-safety-evaluation-monitoring-assessing-and-reporting-of-adverse-drug-responses......Page 642
Ch30-statistics-in-pharmaceutical-safety-assessment......Page 666
Ch31-combination-products-drugs-and-devices......Page 724
Ch32-qualification-of-impurities-degradants-residual-solvents-metals-and-leachables-in-pharmaceuticals......Page 734
Ch33-tissue-cell-and-gene-therapy......Page 744
APPENDIX A......Page 756
APPENDIX B......Page 758
APPENDIX C......Page 761
APPENDIX D......Page 766
APPENDIX E......Page 770
APPENDIX F......Page 867
Index......Page 889