Strategic assessment for nonclinical safety in drug discovery

Abstract

Given that safety (toxicity) liabilities in drug development still account for a large proportion of development discontinuations and market withdrawals, establishing an appropriate safety prediction and evaluation strategy is an important topic. In particular, discontinuation in the late stage of development following large investment has a significant impact. Accurate safety assessment in the early preclinical stage is therefore highly desirable. However, pre-GLP (exploratory) safety evaluation is not subject to regulatory guidelines, and structure and practices accordingly vary widely among companies. Against this background, it can be difficult for non-safety researchers to understand why a particular evaluation/assay system and study design have been selected and tested, and why these differ from those in other companies. This article introduces the background to and concept of a revised strategy for exploratory safety assessment at Astellas, and explains that exploratory safety assessment is not uniform but varies with strategy.