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

Appropriate Biological matrix for BA/BE studies [Bioanalytics]

posted by Ohlbe – France, 2010-10-01 16:39 (5750 d 11:58 ago) – Posting: # 5973
Views: 8,144

Dear all,

❝ Whole blood makes only sense if the drug is extensively bound to erythrocytes and essentially no concentrations would be found in plasma (one of the rare examples is chlorthalidone).

I think regulators would expect whole blood to be used for some drugs which are traditionally measured in whole blood for therapeutic drug monitoring, such as ciclosporin or tacrolimus, independently on whether they can nowadays be measured in plasma or not. Bortezomib would probably be a candidate for whole blood too.

Regards
Ohlbe

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Regards
Ohlbe

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 studiesOhlbe 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 studies jchapdelaine 2011-02-03 18:08
      - Serum vs. plasma Helmut 2011-02-05 19:11