This guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation and Research (CDER) regarding nonclinical studies intended to identify the potential for a drug to cause endocrine-related toxicity.
The goals of this guidance are to:
- Describe how endocrine-related toxicity is assessed using the standard battery of nonclinical tests
- Identify situations in which additional studies should be considered to more fully characterize the endocrine-related toxicity of a drug
This guidance focuses on nonclinical testing designed to assess the potential for a drug to cause endocrine effects that are unintentional and adverse. It does not provide guidance relating to the development of drugs that are intended to interfere with the endocrine system to prevent or treat a particular disease or condition, and it does not provide detailed recommendations regarding clinical studies to investigate adverse endocrine-related activity. Environmental assessment issues are not covered in this guidance.