Bioequivalence and Bioavailability Forum

Lottery or science? [PK / PD]

posted by nobody – 2015-01-13 12:23 (3829 d 06:58 ago) – Posting: # 14279
Views: 9,628

❝ Hope for the best, light some candles in the church

I do this on a regular basis, but it shouldn't be necessary for the scientific evaluation of a robust (!) and meaningful (!) characteristics of a PR formulation

That's the point.

If a parameter is needed to compare exposure at the end of the dosing interval, why not AUCtrough ( :D no joke)? How about: AUC -2h, -1h, 0h prior to next application? 2 additional plasma samples might make your day and safe a lot of volunteers blood (replicate design), so science meets ethics, win-win, I think.

But this Ctrough is neither meaningful nor robust (close to LLOQ and with lots of physiological variability from GI movement to whatever), it's kind of lottery that should never make it through the discussion process of a regulatory guidance document. My opinion...

Complete thread:

• Lottery or science? nobody 2015-01-13 10:21 
  • Lottery or science? ElMaestro 2015-01-13 10:38
    • Lottery or science? nobody 2015-01-13 10:45
      • Lottery or science? ElMaestro 2015-01-13 11:05
        • Lottery or science?nobody 2015-01-13 11:23
          • Lottery: maybe. Science: no. Helmut 2015-01-13 13:50
            • Lottery: maybe. Science: occasionally ElMaestro 2015-01-13 16:45
              • Lottery: maybe. Science: occasionally nobody 2015-01-13 17:16
            • Lottery: maybe. Science: no. nobody 2015-01-13 17:12
              • post additional studies ElMaestro 2015-01-13 17:46
                • post additional studies nobody 2015-01-13 18:28
              • Historic abstract of Cmin in BE Helmut 2015-01-14 01:42
                • Historic abstract of Cmin in BE nobody 2015-01-14 08:42