научно-популярная литература

зарубежная образовательная литература

медицина

фармакология

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 


литературоведение

Drug Safety Evaluation

Clinical Trials Handbook

Development of Therapeutic Agents Handbook

Drug Discovery Handbook

Handbook of Pharmaceutical Biotechnology

Pharmaceutical Manufacturing Handbook

Без серии

Shayne Cox Gad