Drug Safety Evaluation (Pharmaceutical Development Series)

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition 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 TITLE PAGE -- COPYRIGHT PAGE -- CONTENTS -- PREFACE -- ABOUTH THE AUTHOR -- CHAPTER 1 THE DRUG DEVELOPMENT PROCESS AND THE GLOBAL PHARMACEUTICAL MARKETPLACE -- 1.1 INTRODUCTION -- 1.2 THE MARKETPLACE -- 1.3 HISTORY OF MODERN THERAPEUTICS -- 1.4 THE DRUG DEVELOPMENT PROCESS -- 1.5 STRATEGIES FOR DEVELOPMENT: LARGE VERSUS SMALL COMPANY OR THE SHORT VERSUS LONG GAME -- 1.5.1 Do Only What You Must -- 1.5.2 Minimize the Risk of Subsequent Failure -- 1.6 SAFETY ASSESSMENT AND THE EVOLUTION OF DRUG SAFETY -- 1.7 THE THREE STAGES OF DRUG SAFETY EVALUATION IN THE GENERAL CASE -- REFERENCES "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher