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

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

posted by Ohlbe – France, 2013-11-15 16:55 (4608 d 09:24 ago) – Posting: # 11893
Views: 8,275

Dear Nathan,

❝ [...] I also understand that regulators want to standardize analyses. (Although they could standardize on linear up - log down, which would be more accurate than the current standard!)

No guideline says that the linear trapezoidal rule should be used for BE. The method should be stated in the protocol and in the report, that's all. Lin up – log down is perfectly acceptable. Sponsors and CROs are just keeping that habit for whatever reason.

—
Regards
Ohlbe

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 samples jag009 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 samplesOhlbe 2013-11-15 15:55
        
        Lin/log trapezoidal Helmut 2013-11-17 14:55