Partial Replicate Study design for Pilot BE Study [Design Issues]
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
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 [Design Issues]
- 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
- Partial Replicate Study design for Pilot BE Study Dr_Dan 2014-11-11 09:08