Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 14:22 (584 d 08:26 ago) – Posting: # 21245
Views: 3,521

Dear Dr Dan,

Please accept my apology for spelling your name wrongly in my last draft.

Please allow me to ask you why you consider this as a new product? Both the APIs are registered as individual products in market and we are just combining both. Why would you call it as a new product that needs Efficacy and Safety data?

Thank you,
SKM

Complete thread:

Activity
 Admin contact
21,729 posts in 4,543 threads, 1,543 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Saturday 23:49 CEST (Europe/Vienna)

If you want to converse with me,
define your terms.    Voltaire

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