Safety Profile Based on Concordance of Nonclinical Toxicity and Clinical Adverse Drug Reactions for Blood Cancer Drugs Approved in Japan.

Background: In drug development, animal toxicology data are very important for the evaluation of clinical safety. We quantitatively assessed the safety profiles of blood cancer drugs approved in Japan from category I (high) to V (low). We examined the ratios of drug exposure in animals at the no observed adverse effect level to those in humans at the expected therapeutic dose.

Evaluation of Safety Profiles of Blood Cancer Drugs Approved in Japan.

Background: In drug development, the safety of a test drug for human use is first assessed in animal toxicology studies; therefore, the no-observed-adverse-effect-level (NOAEL) and toxicokinetic data are very important for the evaluation of clinical safety. The ratio of drug exposure in animals at the NOAEL to that of humans at the expected therapeutic dose is one of the primary measures for determining the risk-benefit profile of a pharmaceutical. The objective of this study was to evaluate the safety profiles of drugs for blood cancer approved in Japan by examining safety indices (SIs).