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dixit ★ India, 2009-02-13 16:42 (6346 d 14:00 ago) Posting: # 3235 Views: 3,402 |
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Dear all, we are planning for BA/BE studies with suspension, injections, dry syrup, Can any one please tell me what should be the number of retention samples in these cases. Regards, Dixit  |
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Ohlbe ★★★ France, 2009-02-14 17:26 (6345 d 13:16 ago) @ dixit Posting: # 3240 Views: 2,819 |
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Dear Dixit, ❝ Can any one please tell me what should be the number of retention samples ❝ in these cases. For which market ? Did you have a look at the guidance page ? Regards Ohlbe |
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dixit ★ India, 2009-02-16 07:52 (6343 d 22:50 ago) @ Ohlbe Posting: # 3247 Views: 2,757 |
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Dear Ohlbe, It is for USFDA. Regards Dixit |
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Ohlbe ★★★ France, 2009-03-01 14:11 (6330 d 16:31 ago) @ dixit Posting: # 3302 Views: 2,790 |
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Dear Dixit, I checked 21CFR320, §38 and 63. They don't seem to make any difference depending on the formulation. The amount to be retained is "a sufficient quantity to permit FDA to perform five times all of the release tests required in the application or supplemental application." Check with the sponsor how much that would be. For solid oral dosage form there is an upper limit of 300 units each for the test product and the reference product. Double-check the texts again, I'm not a specialist of US markets ! Regards Ohlbe -- Edit: Link corrected for FDA's new site. [Helmut] |
Ing. Helmut Schütz