Bioequivalence and Bioavailability Forum

Failed AUC 0-t [Study Assessment]

posted by Dr_Dan – Germany, 2013-08-29 13:04 (4273 d 21:46 ago) – Posting: # 11377
Views: 8,947

Dear Tina
In order to give you advice I would need some further information:

What was the CVintra for Cmax?
I guess it is a drug with a very long elimination half live, right? Did you use truncated AUC?
If CVintra for Cmax << AUC and short t1/2, have you performed any outlier testing?
What was the point estimator (T/R ratio) for AUC? Maybe the formulation difference is too big to just calculate with CVintra and the usual delta 5%.


                            <<Sample Size Estimation>>                     

                                                                           

  Upper acceptance limit = 125 %

  Lower acceptance limit = 80 %

      Expected ratio T/R = 95.00 %

            Target power = 80.00 %

        Intra-subject CV = 24.0 %



crossover: n=26   

half replicated: n= 20   

full replicated: n= 14



         Estimated power = 80.76665 %

--------------------------------------------------------------------------



**Ref.:

 1. Hauschke D, Steinijans VW, Diletti E and Burke M. Sample size   

    determination for bioequivalence assessment using a multiplicative model.

    Journal of Pharmacokinetics and Biopharmaceutics. 20, 557-561 (1992).  

 2. Julious SA. Tutorial in biostatistics: Sample sizes for clinical trials 

    with normal data.  Statistics in Medicine. 23, 1921-1986 (2004).       

 3. Hauschke D, Steinijans VW and Pigeot I. Bioequivalence studies in drug

    development methods and applications. John Wiley & Sons, New York      

    (2007).

Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Failed AUC 0-t Tina 2013-08-29 09:25
- Failed AUC 0-tDr_Dan 2013-08-29 11:04
  - Failed AUC 0-t Tina 2013-08-29 13:11
  - bear for replicates Helmut 2013-08-29 14:33
- Failed AUC 0-t Helmut 2013-08-29 13:58
  - Failed AUC 0-t Tina 2013-08-29 17:48
    - Correct numbers? Helmut 2013-08-29 18:24
- Failed AUC 0-t luvblooms 2013-08-30 09:23

Failed AUC 0-t [Study As­sess­ment]

Complete thread:

Failed AUC 0-t [Study Assessment]