Evaluation of Safety Profiles of Blood Cancer Drugs Approved in Japan

Conclusions: In cases where the SI is <1.0, no drug safety margin can be assured based on animal data. When extrapolating data from animal studies to safety assessment in clinical studies, safety profile would be one of aspects to be carefully considered in drug development, including postmarketing surveillance.

http://dij.sagepub.com/cgi/content/abstract/50/2/228?rss=1

Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Kubota, S., Saito, K., Ono, S., Kodama, Y. Tags: Global Perspectives Source Type: research