product description page

Drug Safety Evaluation (Hardcover) (Shayne Cox Gad)

Drug Safety Evaluation (Hardcover) (Shayne Cox Gad) - image 1 of 1

About this item

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
Number of Pages: 886
Genre: Medical, Science
Format: Hardcover
Publisher: John Wiley & Sons Inc
Author: Shayne Cox Gad
Language: English
Street Date: November 7, 2016
TCIN: 52022820
UPC: 9781119097396
Item Number (DPCI): 248-39-6163
If the item details above aren’t accurate or complete, we want to know about it. Report incorrect product info.

Guest reviews

Prices, promotions, styles and availability may vary by store & online. See our price match guarantee. See how a store is chosen for you.