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RegisterRetention [Regulatives / Guidelines]
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]
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]
Complete thread:
- RetentionVuas 2021-03-05 19:02 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz