- 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. 895 p.
- Shayne Cox Gad, B.S. Chemistry and Biology, Ph.D. in Pharmacology/Toxicology. Gad Consulting Services, Raleigh, NC (USA).
- Publisher : Wiley-Blackwell
- Publication date (print) : 2016-12
- ISBN (print) : 978-1-119-09739-6
- ISBN (ebook) : 978-1-119-09741-9