Recommended Diagnostic Approach to Documenting and Reporting Skin Findings of Nonhuman Primates from Regulatory Toxicity Studies

摘要

Cutaneous adverse drug reactions (CADRs) in patients are not uncommon, and they are difficult to predict from nonclinical safety studies. Nonhuman primates (NHPs) are predestinated for a high predictivity of adverse drug reactions, and we postulate that this may also be true for CADRs, if skin findings in NHPs are thoroughly worked up, following the diagnostic approach in clinical veterinary dermatology. This article proposes a systematic approach to describe, analyze, and report skin findings that occur in NHP toxicity studies. Implementing this approach may increase the likelihood to differentiate between test item-related cutaneous findings and those that are independent of the test item. This will eventually result in increased relevance of skin findings identified in the scope of an NHP regulatory toxicity study for the risk assessment process to safeguard patients in clinical trials and beyond.