Bioequivalence and Bioavailability Forum • Complicated

Complicated [Design Issues]

posted by ElMaestro – Denmark, 2010-06-07 20:28 (5494 d 12:06 ago) – Posting: # 5459
Views: 9,338

Dear ioanam,

This is a tricky situation. I would encourage you to (ask the man with the money to) seek scientific advise or whatever equivalent is available if your target market is not Europe. You have a complicated drug, complicated info on the ref SPC, and you need to tiptoe through an ethical mine field.

I agree with HS, that a parallel study in patients is likely to be the way to do it.

Best regards
EM.

—
Pass or fail!
ElMaestro

Complete thread:

NTIDs with high variability ioanam 2010-06-07 13:52 [Design Issues]
- NTIDs # HVDs (or not?) Helmut 2010-06-07 14:18
  - NTIDs # HVDs (or not?) ioanam 2010-06-07 18:17
    - ComplicatedElMaestro 2010-06-07 18:28
  - NTIDs # HVDs (or not?) Dr_Dan 2010-06-08 12:24
    - Switch over Helmut 2010-06-08 12:34
      - NTIDs # HVDs (or not?) Relaxation 2010-06-09 22:38
        
        FDA scaling for NTIDs krishna 2013-01-07 14:01
        
        FDA scaling for NTIDs Helmut 2013-01-12 20:06
        
        FDA scaling for NTIDs krishna 2013-01-18 10:04
        
        FDA scaling for NTIDs Helmut 2013-01-20 12:46
        
        FDA scaling for NTIDs krishna 2013-02-01 12:20