Bioequivalence and Bioavailability Forum

>6 sources of matrix [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-03-30 17:16 (4399 d 16:44 ago) – Posting: # 8355
Views: 9,501

Dear John!

❝ Yes the lab did reanalysis and came to the same conclusion (as per their SOP). It's just kind of strange to see value at 0 on period 1 that's all.

OK, at least you know now that it wasn’t pure chance but at true interference.

❝ Have you seen CROs which go the full length and pre-screen subjects for exposure to the study drug prior to the first dosing day?

Only once (in 30+ years) – drug was Δ⁹-THC.
Another time I came across a very difficult ligand-binding assay where matrix effects were common. During method development the CRO screened ~60 subjects and in validation another 30.

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


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Science Quotes

Complete thread:

• 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34 [Regulatives / Guidelines] 
  • 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50
    • 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 20:10
      • Reanalysis if possible Helmut 2012-03-29 23:17
        • Reanalysis if possible jag009 2012-03-30 15:06
          • >6 sources of matrixHelmut 2012-03-30 15:16
            • >6 sources of matrix jag009 2012-03-30 20:40
              • >6 sources of matrix Helmut 2012-03-31 00:23
            • >6 sources of matrix jag009 2012-04-04 16:32
              • Flashback Helmut 2012-04-05 16:10
                • Flashback jag009 2012-04-05 17:51
                  • No correction if ≤5% Cmax Helmut 2012-04-05 18:08
                    • No correction if ≤5% Cmax navoday 2012-08-15 20:37
                      • excluded period(s) Helmut 2012-08-16 16:36
                        • excluded period(s) rajasekharkakarla 2019-09-20 07:57