Bioequivalence and Bioavailability Forum • Sas proc mixed and 4 period partial replicate Cross over

Sas proc mixed and 4 period partial replicate Cross over [Design Issues]

posted by M.tareq – 2016-05-03 13:35 (2908 d 00:23 ago) – Posting: # 16266
Views: 8,255

Hello, can any one please guide me on performing stat analysis of a 4 period 4 seq 3 treatment partial replicate Cross over study, where the ref product only replicate against t1 and t2 for a bioequivlence study of sofosbuvir?
The FDA recommendation is for full replicate and there are little information found regarding a 4 period Cross over with partial replication?
What other effects to account for beside the usual fixed effects in traditional 2x2 Cross over?
Within subject effect, within formulation variability, and carry over effect?
Thanks in advance

Newbie in stat...

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Sas proc mixed and 4 period partial replicate Cross overM.tareq 2016-05-03 11:35 [Design Issues]
- What is the purpose? Helmut 2016-05-03 12:43
  - What is the purpose? M.tareq 2016-05-03 15:06
  - Alpha inflation ? Ohlbe 2016-05-03 15:48
    - Alpha inflation d_labes 2016-05-03 16:06
    - Not with such a high CV Helmut 2016-05-03 17:49
      - High CV? d_labes 2016-05-03 21:07
        
        Acc. to WHO PQTm Helmut 2016-05-03 21:58
        
        Sofosbuvir d_labes 2016-05-04 11:50