Bioequivalence and Bioavailability Forum

Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 18:21 (927 d 13:37 ago) – Posting: # 20025
Views: 3,787

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).
» 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).

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 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