Bioequivalence and Bioavailability Forum • TOST

TOST [PK / PD]

posted by Helmut – Vienna, Austria, 2014-12-29 15:14 (3836 d 13:41 ago) – Posting: # 14200
Views: 11,294

Hi Astea,

❝ We are now to prove bio-inequivalence if it is really takes the place. How to calculate power in this case (I use PowerTOST in R)? We have CV, CI for Cmax with the left margin greater then the proper and N (imbalanced study after excluding drop-outs)...

With a 90% CI of 115–140% bioinequivalence is not formally proven. This would only be the case if the entire CI is outside 80–125%. Note that from the Two One-Sided Tests as proposed by Schuirmann you get two p-values (one for <0.8 and the other one for >1.25). In your case only the one testing for the lower limit will be significant (<0.05). However, since the PE of 127% is already outside the acceptance range you have some strong hints of inequivalence.

The p-values of TOST are not implemented in the current version of PowerTOST. AFAIK Detlew is considering it for one of the next revisions.

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Complete thread:

enterohepatic recycling, how to calculate Kel? Astea 2014-12-28 12:40
- Kel or λz? Helmut 2014-12-28 13:56
  - Kel or λz? Astea 2014-12-28 14:42
    - Kel or λz? Helmut 2014-12-28 15:34
      - Kel or λz? Astea 2014-12-28 17:48
        
        Kel or λz? mittyri 2014-12-28 20:25
        
        Kel or λz? Astea 2014-12-28 21:21
        
        Kel or λz? Helmut 2014-12-29 02:58
        
        Kel or λz? Astea 2014-12-29 10:38
        
        TOSTHelmut 2014-12-29 14:14
        
        PowerTOST d_labes 2014-12-31 13:41
  - Kel or λz? luvblooms 2014-12-29 05:51
    - Kel or λz? nobody 2014-12-29 21:54
      - Kel or λz? luvblooms 2014-12-30 05:25