000 06188cam a22004818i 4500
999 _c89864
_d89864
005 20250320173145.0
006 m |o d |
007 cr_|||||||||||
008 220906s2023 nju ob 001 0 eng
010 _a 2022042521
020 _a9781119755852
020 _a9781119755876
_q(epub)
020 _a9781119755869
_q(adobe pdf)
020 _z9781119755852
_q(cloth)
040 _aDLC
_beng
_cDLC
_erda
041 _aeng.
042 _apcc
050 0 0 _aRA1238
060 1 0 _aQV 771
082 0 0 _a615/.19
_223/eng/20221110
100 1 _aGad, Shayne C.,
_d1948-
_eauthor.
245 1 0 _aDrug safety evaluation /
_cShayne Cox Gad, Dexter W. Sullivan Jr.
250 _a4th edition.
263 _a2212
264 1 _aHoboken, NJ :
_bWiley,
_c2023.
300 _a1 online resource
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
504 _aIncludes bibliographical references and index.
505 0 _aTable of Contents 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
520 _a"This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. This book helps readers understand how the safety of these products are evaluated for use. Extensively revised to reflect up-to-date information, this edition includes changes to the scope of products (vaccines, small synthetic, large protein moieties, cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks. The revised chapter, and inclusion of brand-new chapters, address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (including carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems"--
_cProvided by publisher.
545 0 _aAbout the Author Shayne Cox Gad, PhD, DABT is the Principal of Gad Consulting Services. He has more than 47 years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He has successfully file 138 INDs and authored and edited 52 books, as well as numerous papers, presentations, and other publications. Dexter W. Sullivan, Jr., MS, DABT is Senior Toxicologist at Gad Consulting Services.
588 _aDescription based on print version record and CIP data provided by publisher; resource not viewed.
650 1 2 _aDrug Evaluation, Preclinical
650 2 2 _aDrug Evaluation
650 2 2 _aProduct Surveillance, Postmarketing
655 4 _2Electronic books.
700 1 _aSullivan, Dexter W.,
_cJr.
_eauthor.
856 4 0 _yFull text available at Wiley Online Library Click here to view.
_uhttps://onlinelibrary.wiley.com/doi/book/10.1002/9781119755883
942 _2ddc
_cER