Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 12:18 (557 d 14:04 ago) – Posting: # 21241
Views: 3,548

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]

Complete thread:

Activity
 Admin contact
21,691 posts in 4,534 threads, 1,541 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Monday 03:22 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5