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Dear Alyssa
I guess you are talking about an oral IR formulation, right?
ISCV are not carved in stone, there will always be a certain variability. However, big differences hint on differences in study performance and/or quality of formulations. It is reasonable to assume that the ISCV in the pivotal study will be similar to the pilot study if you use the same CRO (study procedure performance), the same test formulation vs. the same (batch of) reference product and the same bioanalytical method. If costs do not matter you can of course follow the suggestion of the CRO to go for 4 way crossover, replicate design, with ratio 90-111%, ISCV = 35-40%.
I hope this helps
I guess you are talking about an oral IR formulation, right?
ISCV are not carved in stone, there will always be a certain variability. However, big differences hint on differences in study performance and/or quality of formulations. It is reasonable to assume that the ISCV in the pivotal study will be similar to the pilot study if you use the same CRO (study procedure performance), the same test formulation vs. the same (batch of) reference product and the same bioanalytical method. If costs do not matter you can of course follow the suggestion of the CRO to go for 4 way crossover, replicate design, with ratio 90-111%, ISCV = 35-40%.
I hope this helps
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Sample size calculation (Pilot study result vs literature) Alyssa 2020-05-04 04:35 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size calculation (Pilot study result vs literature)Dr_Dan 2020-05-04 08:46
- Sample size calculation (Pilot study result vs literature) Alyssa 2020-05-04 09:26
- Estimation of CVw and/or CVwR Helmut 2020-05-04 12:07
- Estimation of CVw and/or CVwR ElMaestro 2020-05-04 12:14
- Mea culpa! Helmut 2020-05-04 12:40
- It must be Myco ElMaestro 2020-05-04 13:46
- It is, it is! Helmut 2020-05-04 14:07
- It is.... Alyssa 2020-05-05 05:00
- Tutorial Helmut 2020-05-05 12:45
- Tutorial Alyssa 2020-05-08 06:48
- library d_labes 2020-05-08 11:16
- Tutorial (from the start) Helmut 2020-05-08 13:08
- Tutorial (from the start) Alyssa 2020-05-12 04:05
- Tracking down error Helmut 2020-05-12 11:49
- Tracking down error: stringsAsFactors d_labes 2020-05-13 11:34
- R <4.0.0 Helmut 2020-05-13 12:07
- R <4.0.0 ElMaestro 2020-05-13 14:18
- R <4.0.0? Helmut 2020-05-13 14:21
- PowerTOST’s functions with as.character(design) d_labes 2020-05-13 18:50
- PowerTOST’s functions with as.character(design) Helmut 2020-05-13 18:55
- R <4.0.0 ElMaestro 2020-05-13 14:18
- R <4.0.0 Helmut 2020-05-13 12:07
- Tracking down error Alyssa 2020-05-15 05:08
- All’s well that ends well. Helmut 2020-05-15 10:52
- Tracking down error: stringsAsFactors d_labes 2020-05-13 11:34
- Tracking down error Helmut 2020-05-12 11:49
- Tutorial (from the start) Alyssa 2020-05-12 04:05
- Tutorial Alyssa 2020-05-08 06:48
- Tutorial Helmut 2020-05-05 12:45
- It is.... Alyssa 2020-05-05 05:00
- It is, it is! Helmut 2020-05-04 14:07
- It must be Myco ElMaestro 2020-05-04 13:46
- Mea culpa! Helmut 2020-05-04 12:40
- Estimation of CVw and/or CVwR ElMaestro 2020-05-04 12:14
- Sample size calculation (Pilot study result vs literature)Dr_Dan 2020-05-04 08:46
Ing. Helmut Schütz