Drug Safety Evaluation, Third Edition (Hardcover, 3rd Edition)

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

General

Imprint:	Wiley-Blackwell
Country of origin:	United States
Release date:	December 2016
First published:	2017
Authors:	S.C. Gad
Dimensions:	294 x 225 x 52mm (L x W x T)
Format:	Hardcover
Pages:	920
Edition:	3rd Edition
ISBN-13:	978-1-119-09739-6
Categories:	Books > Science & Mathematics > Chemistry > General Books > Medicine > General issues > Medical equipment & techniques > General Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Biology, life sciences > Biochemistry > Toxicology (non-medical) Promotions
LSN:	1-119-09739-8
Barcode:	9781119097396

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