Retention [Regulatives / Guidelines]

posted by Vuas – India, 2021-03-05 20:02 (1141 d 16:15 ago) – Posting: # 22248
Views: 2,412

Hi everyone,
Some dosage forms like buccal tablets, rectal suppositories are not listed in Table -1 and 2 of Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c). However as per note:11, can we proceed for minimum sample retention quantity of 30 units each for test and reference products? Thanks in advance


Edit: Guidance linked. [Helmut]

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