Bioequivalence and Bioavailability Forum • Appropriate Biological matrix for BA/BE studies

Appropriate Biological matrix for BA/BE studies [Bioanalytics]

posted by jchapdelaine – 2011-02-03 19:08 (5619 d 07:55 ago) – Posting: # 6549
Views: 7,552

Is there any publications/literature on the acceptability of using serum or plasma for BE studies? I have an issue as the FDA recently posted a BE recommendation for an analyte stating the use of plasma, however we previously validated the assay using serum. Any help to justify this is welcomed.

Complete thread:

Appropriate Biological matrix for BA/BE studies sambasivarao 2010-10-01 14:02
- Appropriate Biological matrix for BA/BE studies Helmut 2010-10-01 14:27
  - Appropriate Biological matrix for BA/BE studies Ohlbe 2010-10-01 14:39
    - TDM matrix Helmut 2010-10-01 14:46
      - TDM matrix Ohlbe 2010-10-01 17:41
  - Appropriate Biological matrix for BA/BE studies sambasivarao 2010-10-06 06:06
    - Appropriate Biological matrix for BA/BE studiesjchapdelaine 2011-02-03 18:08
      - Serum vs. plasma Helmut 2011-02-05 19:11