Bioequivalence and Bioavailability Forum

Lottery: maybe. Science: occasionally [PK / PD]

posted by ElMaestro  – Denmark, 2015-01-13 17:45 (3831 d 00:13 ago) – Posting: # 14281
Views: 9,626

Hi Hötzi,

❝ I’m eager to learn what the PKWP’s “justification“ was. To my knowledge not a single [sic] paper demonstrating its “merits” is published yet. Science? Gimme a break.

Diplomatic as usual.
I think regulators are sitting on much more comprehensive info than just the papers that are occasionally published. In fairness, sometimes regulators know stuff you and I don't, and the guideline could simply be a consequence of that.
But in such cases it would be really prudent of the agency to publish comments and some useful degree of justification, and not just resorting to either not publishing comments and justification at all, or publishing argumentation that is conveniently vague sentences referring to reviews of the current scientific knowledge incl. study reports available to agencies etc.

We'll see....... or perhaps we won't.

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: occasionallyElMaestro 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