supporting data
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- Data, other than those from formal stability studies, that support the analytical procedures, the proposed re-test period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, small scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing; (2) information regarding test results on containers; and (3) other scientific rationales.
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.