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

posted by heritage – India, 2018-02-17 08:32 (2700 d 20:44 ago) – Posting: # 18427
Views: 5,083

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
Activity
 Admin contact
23,430 posts in 4,931 threads, 1,675 registered users;
68 visitors (0 registered, 68 guests [including 13 identified bots]).
Forum time: 06:16 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

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