Bioequivalence and Bioavailability Forum • Fully Replicated design

Fully Replicated design [RSABE / ABEL]

posted by sirajudeen – India, 2013-09-24 09:00 (4658 d 07:25 ago) – Posting: # 11545
Views: 10,562
(edited on 2013-09-24 11:18)

Dear All,

I would like to obtain some clarifications on fully replicate studies (four period with two treatment, two sequence) on some of the followings in terms of PK and statistics.

Can subjects who complete atleast two periods (random) or atleast two consecutive Periods from study, whether to consider for PK and stat evaluation?
Can the subjects who completed atleast two periods of Test products be considered for within-subject variability of the test product evaluation or the within-subject variability is to be considered only with reference product?
Can the subjects who completed atleast two periods of Test and Reference products can be considered for BE evaluation or the subjects completed all 4 periods with each of test/reference product?

Edit: Category changed. [Dr_Dan]

Complete thread:

Fully Replicated designsirajudeen 2013-09-24 07:00
- Fully Replicated design Dr_Dan 2013-09-24 11:17
  - Fully Replicated design Yvonne 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