Bioequivalence and Bioavailability Forum

Dear Mr.Chakravarthi,

It is possible, you can get dissolution done at lower RPM for Test and Reference. EX: Ur Release media is Purified Water at 50 RPM. U have data in all four media but no discrimination observed. Then in that case get the data generated at 30 RPM in only that media where u have proper profiling. We had the same problem, but this gave the answer for sample selection in BE study. Interestingly, Pivotal BE passed.

Also, as per my understanding, we generate discrimination for PDR to justify, if at all there is any lack of excipient in formulation, then dissolution media should be robust in detecting... which is known as discrimination. This is still debatable...

Regards,
PG

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