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Gad, Shayne Cox

Drug Safety Evaluation

Gad, Shayne Cox - Drug Safety Evaluation, ebook

362,70€

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, Toxicology

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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