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

posted by heritage – India, 2018-02-17 08:32 (2053 d 06:29 ago) – Posting: # 18427
Views: 3,831

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
22,764 posts in 4,776 threads, 1,628 registered users;
16 visitors (0 registered, 16 guests [including 5 identified bots]).
Forum time: 16:02 CEST (Europe/Vienna)

The object of statistics is information.
The objective of statistics is the understanding of information
contained in data.    Irwin and Marylees Miller

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