Drug Safety Evaluation 3e

"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher.

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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