Bioequivalence and Bioavailability Forum • Quot licet Iovi, non licet bovi

Quot licet Iovi, non licet bovi [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2011-10-10 14:57 (5375 d 01:37 ago) – Posting: # 7458
Views: 5,309

Dear both,

THX Dan for the hints. Although the MR GL (1999) was applicable …

Assessment of bioequivalence will be based on AUC_τ, C_max and C_min applying similar statistical procedures as for the immediate release formulations.
Any widening of the acceptance criteria should be established prospectively in the clinical study protocols. They should be justified from a clinical point of view by the applicant.

… the first Q&A document (Jan 2009, A2.d.) stated:

The bioequivalence approach considering usual acceptance limits (80 – 125 %) is applicable for generic MR products. […]
Any widening of the acceptance criteria for C_max should follow the recommendations of the NfG on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98) and the Questions & Answers on the Bioavailability and Bioequivalence Guideline (EMEA/CHMP/EWP/40326/2006).

Therefore for MR products a replicate design was requested in 2009. But the assessor was not blind. Most likely he/she was just fed [sic!] up from too many PPIs…

Quod licet Iovi, non licet bovi

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Complete thread:

Widened acceptance range w. a 2,2,2-study? ElMaestro 2011-10-09 13:44
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
  - Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
    - Quot licet Iovi, non licet boviHelmut 2011-10-10 12:57
      - Cmax of interest? Dr_Dan 2011-10-10 16:57
        
        CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
        
        CI outside 80.00%–125.00%, who cares? Dr_Dan 2011-10-11 09:54
        
        Common sense rulez?! Helmut 2011-10-11 16:27