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Gad, Shayne Cox

Drug Safety Evaluation

Gad, Shayne Cox - Drug Safety Evaluation, ebook

329,10€

Ebook, ePUB with Adobe DRM
ISBN: 9781119097419
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Printing275 pages with an additional page accrued every 3 hours, capped at 275 pages
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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

Keywords: Drug safety evaluation; drug toxicity; preclinical development; clinical development; pharmaceutical safety; drug development; hazard assessment; repeat dose toxicity; safety pharmacology; pharmacovigilance; combination drug products; genotoxicity; carcinogenicity; developmental toxicity; immunogenicity; immunotoxicity; harmonized regulations, Pharmacology & Pharmaceutical Medicine, Veterinary Pharmacology, Toxicology & Therapeutics, Pharmacology & Pharmaceutical Medicine, Veterinary Pharmacology, Toxicology & Therapeutics

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2017
Language
en
Edition
3
Series
Pharmaceutical Development Series
Page amount
918 pages
Category
Medicine, Health Care, Mode
Format
Ebook
eISBN (ePUB)
9781119097419
Printed ISBN
9781119097396

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