Bioequivalence and Bioavailability Forum • BE for HVD (EMA)

BE for HVD (EMA) [Regulatives / Guidelines]

posted by nasir – Jordan, 2014-02-18 08:24 (4513 d 21:07 ago) – Posting: # 12436
Views: 6,000
(edited on 2014-02-18 10:52)

Hi Folks,

Thank you all for this. I beleive Cmax (a single point in PK profile) but not AUC (all points in PK profile) limits widened since is more sensetive to high CV than AUC.

Nasir

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

BE for HVD (EMA) nasir 2014-02-14 06:38
- BE for HVD (EMA): no 2x2 crossover d_labes 2014-02-14 09:27
  - CV >30% in the study Helmut 2014-02-14 14:35
- BE for HVD (EMA) kvgreddy06 2014-02-14 16:18
  - BE for HVD (EMA) PK_Lover 2014-02-14 18:37
    - EMA: No widening of acceptance limits for AUC d_labes 2014-02-14 20:03
    - BE for HVD (EMA) Helmut 2014-02-15 15:10
      - BE for HVD (EMA)nasir 2014-02-18 07:24
        
        Single point metric… Helmut 2014-02-18 13:03
        
        Single point metric… nasir 2014-02-18 19:57
        
        Single point metric… Helmut 2014-02-18 20:38
        
        Single point metric… nasir 2014-02-19 07:09
        
        MR GL – when? Helmut 2014-02-19 13:10