Bioequivalence and Bioavailability Forum

Comparative pharmacokinetics [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2009-01-13 22:28 (6362 d 20:56 ago) – Posting: # 3027
Views: 7,536

Dear ElMaestro!

❝ [...] I do not find that quote utterly clear,

Me not either...

❝ I would be inclined to say that comparative pharmacokinetics [...] would be BE.

I would stick with EMEA's definition that a BE study is a comparative BA study, which is designed to demonstrate BE and the reference is the innovator's product.

In BA we compare essentially the absorption, whereas for example in PK interaction studies also the clearance.
IMHO there's an endless number of possibilities of comparing PK (interactions, disease states, covariates in PopPK like sex, age, creatine clearance, body weight, surface area, ). That's why I aked for more informations about the rationale and design of Santosh's study.

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


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Science Quotes

Complete thread:

• Comparative pharmacokinetics santosh.awale 2009-01-06 05:53 
  • Comparative pharmacokinetics santosh.awale 2009-01-09 06:01
    • Comparative pharmacokinetics JPL 2009-01-09 09:28
    • Comparative pharmacokinetics Helmut 2009-01-09 12:40
    • Comparative pharmacokinetics ElMaestro 2009-01-09 15:38
      • Comparative pharmacokinetics Helmut 2009-01-11 12:59
        • Comparative pharmacokinetics ElMaestro 2009-01-13 14:14
          • Comparative pharmacokineticsHelmut 2009-01-13 21:28
            • Comparative pharmacokinetics santosh.awale 2009-01-15 10:24
              • Comparative pharmacokinetics ElMaestro 2009-01-15 16:15