The Nonclinical Overview should provide a comprehensive and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluations of the pharmaceutical. Relevant guidelines for study conduct should be considered, and any deviations from these guidelines should be discussed and justified. The nonclinical testing strategy should be explained and supported. Comments on the Good Laboratory Practice (GLP) status of the submitted studies should be included. Any connections between nonclinical findings and the quality attributes of the human pharmaceutical, clinical trial results, or effects observed with related products should be highlighted where applicable.

Read the full guidance on the Quality Module.