Posting: # 19409
My Question is:
Please provide clarification related to retention of BABE samples. Is it compulsory to retain pilot study samples or only retention of pivotal study samples are sufficient in order to follow the retention criteria?
1. As per CDSCO guideline "samples used in BA/BE study should be retained by organisation".
2. As per 21 CFR Sec. 320.38 Retention of bioavailability samples "retain an appropriately identified reserve sample of the drug product for which the applicant is seeking approval".