T>MIC for Anti microbial is sufficient to show therapeutic efficacy [Regulatives / Guidelines]

posted by heritage – India, 2018-02-17 08:32 (2246 d 07:52 ago) – Posting: # 18427
Views: 4,066

Hi all

I need one help.

My objective is to replace immediate release formulation one antimicrobial with sustained release formulation of the same antimicribial

Can pharmacodynamic end-point (T>MIC) of Sustained Release formulation establish therapeutic effect and hence waive need to do clinical study? or we have to do a clinical study of Sustained release formulation vs immediate release formulation?

Complete thread:

UA Flag
 Admin contact
22,980 posts in 4,821 threads, 1,655 registered users;
45 visitors (0 registered, 45 guests [including 13 identified bots]).
Forum time: 17:24 CEST (Europe/Vienna)

Never, never, never use any software!
Never, never, never trust any computer!    Detlew Labes

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