Bioequivalence and Bioavailability Forum • FDA scaling for NTIDs

FDA scaling for NTIDs [Design Issues]

posted by krishna – India, 2013-01-18 11:04 (3977 d 18:32 ago) – Posting: # 9889
Views: 6,590

Hi Helmut,

Thanks for your reply.

❝ Hhm, \(\small{\sqrt{0.80\times 0.93}\neq 0.86}\). If I interpret your example right the study was a full replicate in 32 subjects.

It is 86.25.

❝ The study passes all criteria. What is the problem?

My problem is, here %(T/R): 86.25, it is far way from the 100 and R-R %CV: 26. Due to higher CV it is passing SABE (it would have been failed in SABE if it had low variability). Then how test can be assured with therapeutic equivalence as Reference with out point estimate constraint ?

Thanks,

Krishna.

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
    - Complicated ElMaestro 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 NTIDskrishna 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