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

posted by ElMaestro  – Denmark, 2018-02-17 13:11 (2309 d 03:37 ago) – Posting: # 18428
Views: 3,538

Hi Heritage,

❝ 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?

This is a strategy that works for some developers, but mainly in EU. It does require that you know a lot about the ref. product from publications or from PARs and that the regulators you talk to are friendly. It may vary from agency to agency.
I would seek sc.advice for a 10.3 submission in EU, or approach FDA for a dialogue (controlled corr.) for a prospective 505(b)(2) development.

T>MIC in plasma is a good guess, but depending on the ADME caracteristics it may be not-so-well correlated with efficacy. Look for example at Azitromycin. This is an area were the fine distinction between rate and extent of the API being absorbed vs rate and rate of the API becoming available at the site of action seems muy importante.

Seek regulatory dialogue. Lots of it.

Pass or fail!

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