Bioequivalence and Bioavailability Forum • About "PK repeats"

About "PK repeats" [Software]

posted by Ohlbe – France, 2010-10-21 18:38 (5354 d 13:45 ago) – Posting: # 6070
Views: 16,021

Dear Helmut,

❝ Found an interesting White Paper from "The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis"

Yes, this yearly event is gaining importance and audience. Nice programme each year. Next year will be on "Recent findings from regulatory agencies" !

❝ Following the presentation, a comment was brought forth stating that regulatory agencies recommend against performing PK repeats

Unfortunately. But remember the discussions at the EBF/EUFEPS meeting in Brussels in April: on the European side there is still some hope that the ban will be restricted to BE trials only, not to other PK trials. And there is still a possibility in the draft for repeats for lab investigations. So we are not completely loosing our time.

Best regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

BLQ values in Winnonlin Dr. Harish L. Rao 2009-09-10 07:53 [Software]
- BLQ values in Winnonlin Ohlbe 2009-09-11 00:18
  - BLQ values in Winnonlin > Status codes tool SDavis 2009-09-11 08:13
    - BLQ values in Winnonlin > Status codes tool Ohlbe 2009-09-11 22:19
      - Irregular profiles Helmut 2009-09-14 17:11
        
        About "PK repeats" Ohlbe 2009-09-14 22:01
        
        About "PK repeats" Helmut 2010-10-21 15:51
        
        About "PK repeats"Ohlbe 2010-10-21 16:38
        
        About "PK repeats" Helmut 2010-10-21 17:01
        
        About "PK repeats" Ohlbe 2010-10-21 17:32
        
        slowly going off-topic Helmut 2010-10-21 18:47
        
        About "PK repeats" ElMaestro 2010-10-21 16:56
        
        About "PK repeats" Helmut 2010-10-21 18:02
        
        BLQ Values in Winnonlin Dr. Harish L. Rao 2009-09-15 05:45