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

posted by heritage – India, 2018-02-17 08:32 (2287 d 19:46 ago) – Posting: # 18427
Views: 4,190

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?

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