Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 12:18 (201 d 05:35 ago) – Posting: # 21241
Views: 3,125

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
21,084 posts in 4,398 threads, 1,468 registered users;
online 9 (0 registered, 9 guests [including 2 identified bots]).
Forum time: Monday 18:54 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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