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Registerone study, one method [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2019-03-13 18:23 (1291 d 06:38 ago) – Posting: # 20026
Views: 4,168
Salam Osama,
» […] 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 ??
Honestly, I would not feel comfortable with such an approach as well. Even if two methods are fully validated and cross-validated against each other. Though, at least in a crossover it should be OK.
I faced very few examples that a validated method (you know, only spiked samples…) turned out to perform “not so good” on real samples. In these cases we developed another method and re-analysed all samples with the new method. I cannot imagine a situation when someone would change a suitable method within a study just for fun.
» […] 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 ??
Honestly, I would not feel comfortable with such an approach as well. Even if two methods are fully validated and cross-validated against each other. Though, at least in a crossover it should be OK.
I faced very few examples that a validated method (you know, only spiked samples…) turned out to perform “not so good” on real samples. In these cases we developed another method and re-analysed all samples with the new method. I cannot imagine a situation when someone would change a suitable method within a study just for fun.
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 trial Ohlbe 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 methodHelmut 2019-03-13 18:23
- Multiple methods within a single trial Ohlbe 2019-03-13 18:21
- Consultation period? Helmut 2019-03-04 01:08
Ing. Helmut Schütz