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RegisterSample Size Benefits of Replicate Design with ABE [Power / Sample Size]
Folks, I have three questions:
(1) If you conduct a full replicate crossover design BE study (T x 2, R x 2, e.g., TRTR|RTRT) is there any sample size efficiency (fewer patients required) with ABE analysis or is it no different (in terms of sample size) than a non-replicate crossover design BE study (T x1, R x 1) with ABE analysis.
(2) For demonstrably HVD (WSV >30%), why do some product specific guidance for ANDA suggest (or allow) full replicate designs and others do not mention this approach?
(3) For demonstrably HVD (WSV >30%), why do some Clinical Divisions object to use of full replicate design studies in 505(b)(2) NDAs?
Any input would be appreciated!
(1) If you conduct a full replicate crossover design BE study (T x 2, R x 2, e.g., TRTR|RTRT) is there any sample size efficiency (fewer patients required) with ABE analysis or is it no different (in terms of sample size) than a non-replicate crossover design BE study (T x1, R x 1) with ABE analysis.
(2) For demonstrably HVD (WSV >30%), why do some product specific guidance for ANDA suggest (or allow) full replicate designs and others do not mention this approach?
(3) For demonstrably HVD (WSV >30%), why do some Clinical Divisions object to use of full replicate design studies in 505(b)(2) NDAs?
Any input would be appreciated!
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Biostatistically Challenged CEO
Biostatistically Challenged CEO
Complete thread:
- Sample Size Benefits of Replicate Design with ABESereng 2023-05-24 15:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample Size Benefits of Replicate Design with ABE dshah 2023-05-25 09:56
- Dropouts less problematic Helmut 2023-05-25 16:27
Ing. Helmut Schütz