Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 12:18  – Posting: # 21241
Views: 2,029

Hello!

Thank you so much for the thoughtful response. I appreciate your approach towards the feasibility of the FDC and its probability to get registered.

We have not done a great deal in terms of formulation development. We only evaluated the possibility/feasibility of having a solution formulation with the current set of solvents/ formulation pH, etc. for the individual products. It appears that we may be able to combine these products with all existing solvents which have a track record of safety.

If we assume that 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, what studies do we need to perform? My guess is that we 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.

Thanks a lot,
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[Helmut]

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