Bioequivalence and Bioavailability Forum • BE for HVD (EMA)

BE for HVD (EMA) [Regulatives / Guidelines]

posted by kvgreddy06 – India, 2014-02-14 17:18 (4520 d 00:06 ago) – Posting: # 12427
Views: 6,243

❝ As per EMA guideline, 3 way or 4 way replicate design should be done for HVD in order to be able to widen Cmax limits.

Why EMA suggesting widening of limits for Cmax only why not AUC?

'AUC is also one of the primary PK parameter'.

Thanks
KVGR

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

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