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RegisterReplicate Design/Scaled ABE approach [Design Issues]
Can we revert to the average BE approach if within subject variances obtained from a replicate design/scaled ABE (TRTR) show that the drug is NOT highly variable, or can we apply the usual BE assessment criteria of 90% CI (80-125%) using data from periods I & II? The reason for conducting a replicate design was that a high CV estimated from the ANOVA model was obtained in a previous ABE study, an indicator for high within subject variability and data from published literature. The intention for using replicate design and for turning back to the average BE approach (if the drug is not highly variable), would be stated in the protocol.
I would appreciate your thoughts/comments on the above. Thanks.
I would appreciate your thoughts/comments on the above. Thanks.
Complete thread:
- Replicate Designs for Average Bioequivalence joyjac 2006-01-27 00:58
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate Designs for Average Bioequivalence H_Rotter 2006-01-27 12:15
- Replicate Designs joyjac 2006-01-31 06:41
- Replicate Design/Scaled ABE approachjoyjac 2006-08-23 09:47
- Replicate Design/Scaled ABE approach H_Rotter 2006-08-23 12:09
- Replicate Designs for Average Bioequivalence H_Rotter 2006-01-27 12:15
Ing. Helmut Schütz