Year of Publication: 2016
Author(s) : Shayne Cox Gad
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Drug Safety Evaluation, 3rd Edition helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development. It also explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity.
This book contains a vast coverage of the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars as well as revision of 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.
This is the latest edition to a priceless series of helpful guides and along with its most recent instalment, Drug Safety and Evaluation brings nearly twenty percent of all-new and thoroughly updates existing content from the last edition.