Bioequivalence and Bioavailability Forum

EMA: No widening of acceptance limits for AUC [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2014-02-14 21:03 (4518 d 21:13 ago) – Posting: # 12430
Views: 6,382

Dear PK_Lover,

❝ I would say that it is because a wider difference in AUC is considered clinically relevant.

I'm not quite sure if this gets the point. I have the impression that this decision was driven purely by 'political' reasons (Whatever these reasons were ).

If it were due to some 'scientific' reasons I would not understand why the FDA does allow widening (or better said scaled ABE) also for AUC.

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 AUCd_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