Bioequivalence and Bioavailability Forum • one study, one method

one study, one method [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-03-13 19:23 (2198 d 04:48 ago) – Posting: # 20026
Views: 5,727

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). :confused:

❝ 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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Complete thread:

Draft ICH M10 published Ohlbe 2019-03-03 23:18 [Regulatives / Guidelines]
- 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
  - one study, one methodHelmut 2019-03-13 18:23