Bioequivalence and Bioavailability Forum • Two-Stage Design with Fully replicate for CANADA?

Two-Stage Design with Fully replicate for CANADA? [Two-Stage / GS Designs]

posted by Rakesh_20 – India, 2015-01-22 11:26 (3383 d 10:58 ago) – Posting: # 14309
Views: 6,315

Dear Sir,

I have following concern :
For Canadian submission, can we consider the Fully replicated crossover design with two-stage sequential approach for BE study? and how TPD will look at this?

Thanks and Regards,
Rakesh

Complete thread:

Two-Stage Design with Fully replicate for CANADA?Rakesh_20 2015-01-22 10:26
- Two-Stage Design with Fully replicate for Canada ElMaestro 2015-01-22 10:56
- RSABE/TSD-combo Helmut 2015-01-22 12:37
  - Fully replicated-conventional ABE/TSD-combo Rakesh_20 2015-01-23 06:32
    - Simulations mandatory Helmut 2015-01-23 12:41