Drug Safety Evaluation

Product Number: EB00692474
Released: Dec 24, 2016
Business Term: Purchase
ISBN: #9781119097419
Publisher: Wiley
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Description

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

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Author(s): Shayne Cox Gad
Genre: Science
Original Publish Date: Dec 01, 2016

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