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rgamage ☆ 2012-02-13 04:53 (5239 d 04:50 ago) Posting: # 8111 Views: 4,733 |
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Could you please give your opinion on the following case for ANDA. generic 100mg vs reference product 100mg f2 pass generic 50mg vs reference product 50mg f2 pass generic 25mg vs reference product 25mg f2 pass generic 100mg vs reference product 100mg BE pass Is this sufficient for a biowaiver for generic 50mg and 25mg Or Do we have to show generic 100mg vs generic 50mg f2 pass generic 100mg vs generic 25mg f2 pass As well? Reason is smaller tablets dissolution rates are faster and fail to pass f2 in most conditions. |
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Dr_Dan ★★ Germany, 2012-02-13 12:35 (5238 d 21:08 ago) @ rgamage Posting: # 8116 Views: 3,800 |
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Dear rgamage sorry, there has been a misunderstanding. You have to show similarity within your formulation. If you demonstrated BE between your generic 100mg vs reference product 100mg, then you have to show that your generic 100mg vs generic 50mg f2 passes and your generic 100mg vs generic 25mg f2 passes in order to waive the BE study. If smaller tablets show dissolution rates which are faster and fail to pass f2 in most conditions, you should evaluate if your method is not overdiscriminating. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz