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priyanka12345 ☆ India, 2018-05-09 17:57 (2172 d 13:16 ago) Posting: # 18758 Views: 2,492 |
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Dear All As per FDA guidance for industry on Handling and Retention of BA and BE Testing Samples the following is stated. Because the Agency has limited experience with the retention and testing of non-solid oral dosage forms, the Agency is unable to recommend an upper limit for the retention of non-solid oral dosage forms at this time. Can any one please let me know how much quantity is required as reserve samples for suspension. Regards, PRIYA Edit: Guidance linked and subject line changed. Please don’t shout! [Helmut] |
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anky1212 ☆ India, 2018-05-31 15:29 (2150 d 15:44 ago) @ priyanka12345 Posting: # 18830 Views: 1,777 |
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Dear Priyanka, As per USFDA guidance, "The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. " Same need to follow. Edit: Guidance linked. [Helmut] |
Ing. Helmut Schütz