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RegisterMultiple methods within a single trial [Regulatives / Guidelines]
Dear Osama,
I would reverse the question: why would you use two different methods, or two different technologies, within a single BE trial, with the risk of increasing variability ? We're not talking of 2 different trials here (where one can be done at one CRO and the other at another CRO, with a different method).
❝ on the other hand, The use of two methods or technologies within a
❝ comparative BA/BE study is strongly discouraged:. (i.e not applicable at all also with cross-validation).
❝ Why ??
I would reverse the question: why would you use two different methods, or two different technologies, within a single BE trial, with the risk of increasing variability ? We're not talking of 2 different trials here (where one can be done at one CRO and the other at another CRO, with a different method).
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Draft ICH M10 published Ohlbe 2019-03-03 23:18 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Consultation period? Helmut 2019-03-04 01:08
- EU/EEA Ohlbe 2019-03-14 23:16
- ICH M10 draft wienui 2019-03-13 18:06
- Multiple methods within a single trialOhlbe 2019-03-13 18:21
- Multiple methods within a single trial wienui 2019-03-13 18:44
- Multiple methods within a single trial Ohlbe 2019-03-13 19:10
- Multiple methods within a single trial wienui 2019-03-13 19:35
- Multiple methods within a single trial Ohlbe 2019-03-13 23:01
- Multiple methods within a single trial wienui 2019-03-13 19:35
- Multiple methods within a single trial Ohlbe 2019-03-13 19:10
- Multiple methods within a single trial wienui 2019-03-13 18:44
- one study, one method Helmut 2019-03-13 18:23
- Multiple methods within a single trialOhlbe 2019-03-13 18:21
- Consultation period? Helmut 2019-03-04 01:08
Ing. Helmut Schütz