Bioequivalence and Bioavailability Forum • EMA MR Draft Guidelines Application

EMA MR Draft Guidelines Application [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-09-17 15:35 (4665 d 21:26 ago) – Posting: # 11504
Views: 3,819

Hi Jay,

❝ […] If Yes then suppose the draft guidelines get finalised before submission, then will it raise query?

(1) Yes and (2) maybe.

❝ Otherwise can we add statement in the protocol regarding that?

Sure. The more you deviate from the current NfG, the more complicated it gets.

❝ As per current guideline, in SD Cmax & AUCt as primary while in MD, Cminss, Cmaxss and AUCtau as primary.

❝

❝ Shall one add pAUC in secondary parameter considering the draft guidelines?

Why not? The problems start with the truncation time point (which has to be prespecified). I guess I will not have been the only one objecting against τ/2. The first pAUC might be highly variable (though widening of the acceptance range might be possible if the study was performed in a replicate design). If in doubt, go for a scientific advice.

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Complete thread:

EMA MR Draft Guidelines Application Jay 2013-09-16 15:39
- EMA MR Draft Guidelines Application jag009 2013-09-16 17:30
- EMA MR Draft Guidelines ApplicationHelmut 2013-09-17 13:35
  - EMA MR Draft Guidelines Application Jay 2013-12-23 11:00
    - EMA MR Draft Guidelines Application Helmut 2013-12-23 13:54
      - EMA MR Draft Guidelines Application Jay 2013-12-23 14:54
        
        Science first! Helmut 2013-12-23 15:41