Bioequivalence and Bioavailability Forum • Fully Replicated design

Fully Replicated design [RSABE / ABEL]

posted by Yvonne – 2013-10-14 11:39 (4640 d 20:02 ago) – Posting: # 11660
Views: 9,226

❝ subjects who completed two periods of Test products can be considered for within-subject variability of the test product (this is the idea of the full replicate to evaluate the within-subject variability of the reference as well as of the test product).

Is it acceptable to include subjects that completed two periods of reference product (and no periods with test product) in the within subject variability calculation of the reference product used for widening? These subjects are (per definition) different from the subjects ("population") used for the test/ref calculation.

Complete thread:

Fully Replicated design sirajudeen 2013-09-24 07:00
- Fully Replicated design Dr_Dan 2013-09-24 11:17
  - Fully Replicated designYvonne 2013-10-14 09:39
    - RR values only Helmut 2013-10-14 17:28
      - RR values only d_labes 2013-10-14 18:38
        
        RR values only Helmut 2013-10-14 19:21
        
        RR values only Yvonne 2013-10-23 15:20
        
        RR values only Helmut 2013-10-23 17:51
        
        RR values only Yvonne 2013-10-24 09:01