Bioequivalence and Bioavailability Forum • Partial Replicate Study design for Pilot BE Study

Partial Replicate Study design for Pilot BE Study [Design Issues]

posted by Jay – India, 2014-11-11 07:21 (4244 d 01:38 ago) – Posting: # 13854
Views: 6,817

Dear friends,

For highly variable drugs with intrasubject CV more than 30% we go for partial replicate, reference replicated study design.

If we are proceeding with such HVDP, is the partial reference replicated study design for pilot study recommended?

Thanks in advance.

Regards,
Jay

Complete thread:

Partial Replicate Study design for Pilot BE StudyJay 2014-11-11 06:21
- Partial Replicate Study design for Pilot BE Study Dr_Dan 2014-11-11 09:08
  - Partial Replicate Study design for Pilot BE Study Jay 2014-11-11 11:03
- Partial replicate pivotal study: why? Helmut 2014-11-11 11:31