The future of drug safety testing: expanding the view and narrowing the focus.
Drug safety remains a high profile issue at a time when the cost and time required to develop a new drug are at an all time high. Balancing risk against the expected clinical benefit is the primary purpose of preclinical and clinical testing. We offer an expanded view on the application of predictive strategies and technologies to early safety decisions and suggestions to narrow the focus for improving preclinical safety testing to the problems that contribute most to adverse drug reactions.
Stevens
James L
JL
Division of Toxicology, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285, United States. stevens_james_l@lilly.com
Baker
Thomas K
TK
D000818:Animals; D002986:Clinical Trials as Topic; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D013678:Technology, Pharmaceutical / Q000379:methods; D018675:Toxicity Tests / Q000639:trends*