Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 13:21 (1505 d 23:22 ago) – Posting: # 21242
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Dear Dr Ken,

Thank you so much for your response. Why would we need effiacy and safety data when we don't plan to use any new solvent in the solution?

The FDC solution can be made at midway pH of 5 (one API is 8 and other is 4) with the help of existing solublizers that are safe and stable, we should only need to perform a Three way Three period Bioequivalence study with the API based 2 individual product with that of FDC to prove the bioequivalency of both the API for the FDC. I don't see any reason for safety and efficacy study requirement. Please correct me if wrong.

Cheers,
SKM

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5!
BTW, Dan ≠ Ken. It’s unpolite to not even get the name of other members right. [Helmut]

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