Bioequivalence and Bioavailability Forum • Single point metric…

Single point metric… [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-02-18 14:03 (4510 d 23:18 ago) – Posting: # 12437
Views: 5,879

Hi Nasir,

❝ 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.

Yes, it it correct that C_max as a single point metric is inherently more variable than AUC. But still: Some products are highly variable in AUC as well – and have to be shown to be safe and efficacious despite their high variability. Therefore, in the EU we have to deal with politics rather than science.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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