Immediate release fixed dose combination product [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-03-11 14:22  – Posting: # 21245
Views: 1,976

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
20,456 posts in 4,296 threads, 1,413 registered users;
online 15 (1 registered, 14 guests [including 11 identified bots]).
Forum time (Europe/Vienna): 20:47 CEST

No one wants to learn from mistakes, but we cannot learn enough
from successes to go beyond the state of the art.    Henry Petroski

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