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f2 Calculation For Rapidly Dissolving FPPs [Dissolution / BCS / IVIVC]

posted by Obinoscopy - Nigeria, 2018-04-22 15:11  - Posting: # 18718
Views: 2,370

Dear All,

Even though I have not come across this scenario in practice, I am imagining a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?

I am aware, the requirements are different for different NRAs (USFDA, EMEA, WHO, etc). I will appreciate if these are taken into account when answering this question.

Regards,

Scopy

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