Bioequivalence and Bioavailability Forum • BE trial design as partial replicate and two stage

BE trial design as partial replicate and two stage [Regulatives / Guidelines]

posted by Silva – Portugal, 2014-04-17 10:57 (4453 d 21:22 ago) – Posting: # 12846
Views: 3,999

Dear all

Is it advisable to use two stage design approach in partial replicate design?
If yes, which alpha level should be used for the second stage (combined stage I + stage II data)?

Best regards
Silva

Complete thread:

BE trial design as partial replicate and two stageSilva 2014-04-17 08:57
- BE trial design as partial replicate and two stage ElMaestro 2014-04-17 09:17
  - BE trial design as partial replicate and two stage Silva 2014-04-17 09:36
    - EMA = PSRPH? Helmut 2014-04-17 15:33