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 ...
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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
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Add this copy of Drug Safety Evaluation, Third Edition (Pharmaceutical to cart. $350.72, new condition, Sold by Media Smart rated 3.0 out of 5 stars, ships from Hawthorne, CA, UNITED STATES, published 2016 by John Wiley & Sons.