Bioequivalence and Bioavailability Forum • Crossover: samples of p1 and p2 in different batches?

Crossover: samples of p1 and p2 in different batches? [Bioanalytics]

posted by Ravuri sindhura – India, 2019-09-18 21:16 (1944 d 05:04 ago) – Posting: # 20614
Views: 9,888

As per FDA Bioanalytical method validation Guidance for Industry "All study samples from subject should be analysed in a single run, especially for studies designed with repeated measures from individual subjects(eg; crossover or sequential design required for BE studies)".
Can the study samples of same subject in more than single run for cross over design can be analysed i'e analysis of P1 samples and P2 samples can be carried out separately in two different runs? If yes, how it need to be justify to regulatory?

Edit: Category and subject line changed; see also this post #1, #2. Please follow the Forum’s Policy. [Helmut]

Complete thread:

Crossover: samples of p1 and p2 in different batches?Ravuri sindhura 2019-09-18 19:16 [Bioanalytics]
- Crossover: samples of p1 and p2 in different batches? dshah 2019-09-19 09:16
  - Leads to a (pseudo-) period effect Helmut 2019-09-19 15:33
    - Leads to a (pseudo-) period effect ? Ohlbe 2019-09-19 15:50
      - Leads to a (pseudo-) period effect ? Helmut 2019-09-19 15:59
        
        Leads to a (pseudo-) period effect ? nobody 2019-09-19 16:21
        
        Almost entirely OT Helmut 2019-09-19 17:22
        
        Almost entirely OT nobody 2019-09-19 17:46
        
        Completely OT Helmut 2019-09-19 18:08
        
        Leads to a (pseudo-) period effect ? dshah 2019-09-20 07:52
        
        Leads to a (pseudo-) period effect ? nobody 2019-09-20 08:00
        Run ≠ batch? Helmut 2019-09-20 09:42
        
        Run ≠ batch Ohlbe 2019-09-20 10:37
        Run ≠ batch? dshah 2019-09-23 07:43
        
        Run ≠ batch? nobody 2019-09-23 08:36
    - Leads to a (pseudo-) period effect Ravuri sindhura 2019-09-23 13:04