Bioequivalence and Bioavailability Forum

Serum vs. plasma [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2011-02-05 20:11 (5624 d 11:51 ago) – Posting: # 6563
Views: 7,589

Dear John,

please see the Policy.

❝ Is there any publications/literature on the acceptability of using serum or plasma for BE studies?

AFAIK no.

❝ I have an issue as the FDA recently posted a BE recommendation for an analyte stating the use of plasma,

I didn't check all 795 specific guidances, but the FDA seems to generally recommend plasma.

❝ […] however we previously validated the assay using serum.

I guess you don't want to ask FDA (might take ages to get a 'nonbinding' answer)?
From a PK point of view it makes absolutely no difference whether you analyze serum or plasma. Since you have a validated method, you obviously bypassed the drawbacks of using serum mentioned here. Method transfer from plasma to serum is easy, but the other way 'round cumbersome.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

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 studies jchapdelaine 2011-02-03 18:08
        • Serum vs. plasmaHelmut 2011-02-05 19:11