Bioequivalence and Bioavailability Forum • Fully replicated-conventional ABE/TSD-combo

Fully replicated-conventional ABE/TSD-combo [Two-Stage / GS Designs]

posted by Rakesh_20 – India, 2015-01-23 07:32 (3757 d 13:36 ago) – Posting: # 14313
Views: 5,902

Dear Both,

Thank you so much for the reply.

❝ If you want to run a fully replicate design for conventional ABE (no scaling) IMHO that should be doable. Start your own simulations.

So, if we consider Fully replicated crossover design-conventional ABE with two-stage sequential approach for BE study then, is it acceptable to canadian submission?

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-comboRakesh_20 2015-01-23 06:32
    - Simulations mandatory Helmut 2015-01-23 12:41