Bioequivalence and Bioavailability Forum • AUC72: NDAs

AUC72: NDAs [Design Issues]

posted by jag009 – NJ, 2012-05-14 17:22 (5140 d 23:48 ago) – Posting: # 8565
Views: 5,619

Hi Helmut,

❝ IMHO that’s an exception. Think about nonlinear PK (saturation, autoinduction). In dose-proportionality studies we are not only interested in absorption but also in detecting potential changes in clearance and therefore would assess primarily AUC_0-∞.

Sorry I wasn't clear in the last email. I meant dosage strength proportionality study (2x100 vs 1x200), not dose proportionality study (100 mg vs 2x100 mg).

In any case, it makes sense to use AUC0-72 for BA studies since I am dealing with the same compound, same indication etc etc and just a change from a tablet to a capsule formulation (vice versa)

Thanks

John

Complete thread:

Parallel study as pilot for long half life drug jag009 2012-05-07 15:13 [Design Issues]
- Parallel study as pilot for long half life drug Dr_Dan 2012-05-07 16:00
  - Parallel study as pilot for long half life drug d_labes 2012-05-07 16:24
  - Parallel study as pilot for long half life drug jag009 2012-05-07 18:15
    - AUC72 Helmut 2012-05-07 19:31
      - AUC72 jag009 2012-05-07 20:15
        
        AUC72 Dr_Dan 2012-05-08 12:17
        
        AUC72 jag009 2012-05-10 15:15
        
        AUC72: NDAs Helmut 2012-05-10 15:56
        
        AUC72: NDAsjag009 2012-05-14 15:22