Bioequivalence and Bioavailability Forum • Multiple methods within a single trial

Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 19:21 (2661 d 07:45 ago) – Posting: # 20025
Views: 7,318

Dear Osama,

❝ 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). :confused:

❝ 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

Complete thread:

Draft ICH M10 published Ohlbe 2019-03-03 23:18
- 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
  - one study, one method Helmut 2019-03-13 18:23