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Keath ☆ India, 2014-03-18 13:27 (4486 d 09:30 ago) Posting: # 12651 Views: 3,318 |
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Dear All, I have doubt regarding the sample retention as per the FDA guidance. In the trasdermal formulations, there are many tests to be performed for generation of the complete release profile for which it will cross the limit of 300 (for solid oral formulation) as mentioned in the guidance. My query is that should i have to consider upper limit of 300 units as or i have to retain 5 times of the complete release profile?? Thanks in advance!! |
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Dr_Dan ★★ Germany, 2014-03-19 12:43 (4485 d 10:15 ago) @ Keath Posting: # 12666 Views: 2,790 |
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Dear Keath The FDA guideline states that as a general rule 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. Because since at the time of releasing the guideline the FDA had limited experience with the retention and testing of non-solid oral dosage forms, the FDA was unable to recommend an upper limit for the retention of these products (including transdermal patches). Therefore I suggest keeping the five times quantity (even if this means much more than 300 samples) unless you have a scientific rationale for a less amount. The decision is in the responsibility of the sponsor. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Keath ☆ India, 2014-03-24 10:47 (4480 d 12:11 ago) @ Dr_Dan Posting: # 12692 Views: 2,568 |
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Dear Dr. Dan Thank you for sharing your views |
Ing. Helmut Schütz