Log in
RegisterFailed AUC 0-t [Study Assessment]
Dear Tina
In order to give you advice I would need some further information:
Kind regards
Dan
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
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Failed AUC 0-t Tina 2013-08-29 09:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 Tina 2013-08-29 17:48
- Failed AUC 0-t luvblooms 2013-08-30 09:23
- Failed AUC 0-tDr_Dan 2013-08-29 11:04
Ing. Helmut Schütz