Bioequivalence and Bioavailability Forum • Add an arm to two way BE study

Add an arm to two way BE study [Design Issues]

posted by intuitivepharma – India, 2015-07-15 11:43 (3995 d 22:10 ago) – Posting: # 15085
Views: 7,198

Dear All,

As we are aware that this is a crippled design [though not intentionally intended], now what should be the best statistical approach that should be employed to have a better understanding [as this is only a pilot study] of true formulation performance [Treatment – C] from the available data of the add-on arm. There would be two sequences as of now, ABC & BAC. Should I,

Analyze as per 3 way crossover with a modified CI
Exclude all occurrences of Treatment – B to compare A & C and vice versa [EU Criteria]

Can our captains enlighten us with better procedures than the above mentioned if any?

Regards,
IP.

—
Thanks & Regards,
IP.

Complete thread:

Add an arm to two way BE study AngusMcLean 2015-07-13 14:47
- Add an arm to two way BE study ElMaestro 2015-07-13 17:39
  - Add an arm to two way BE study Dr_Dan 2015-07-13 18:00
    - Add an arm to two way BE studyintuitivepharma 2015-07-15 09:43
  - Add an arm to two way BE study AngusMcLean 2015-07-14 00:02
    - Add an arm to two way BE study Dr_Dan 2015-07-16 09:18
    - Add an arm to two way BE study ElMaestro 2015-07-16 15:21
      - It's all over now d_labes 2015-07-17 08:12