Bioequivalence and Bioavailability Forum • Using sampling “windows” for PK blood samples

Using sampling “windows” for PK blood samples [Design Issues]

posted by jag009 – NJ, 2013-10-25 07:12 (4631 d 15:53 ago) – Posting: # 11763
Views: 8,534

Hi Mittyri,

❝ Nathan Teuscher does not explain a type of trial. So I'm interested in opinion of the colleagues who are working with BEQ protocols.

His conclusion was based on AUC being similar between the two sampling time schemes which I agree. For BE studies we need to determine both AUC and Cmax equivalence between test and reference. Therefore the PK time point selection is important (if not critical).

John

Complete thread:

Using sampling “windows” for PK blood samples mittyri 2013-10-23 09:53
- Using sampling “windows” for PK blood samples jag009 2013-10-23 16:50
  - Using sampling “windows” for PK blood samples mittyri 2013-10-24 15:35
    - Using sampling “windows” for PK blood samplesjag009 2013-10-25 05:12
      - Disagree with Nathan Helmut 2013-10-28 15:48
        
        Disagree with Nathan jag009 2013-10-28 20:36
      - Using sampling “windows” for PK blood samples teuscher 2013-11-15 03:55
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 10:32
        
        Using sampling “windows” for PK blood samples teuscher 2013-11-15 15:16
        
        Using sampling “windows” for PK blood samples Ohlbe 2013-11-15 15:55
        
        Lin/log trapezoidal Helmut 2013-11-17 14:55