Bioequivalence and Bioavailability Forum

Overpowering [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-07-30 18:51 (4715 d 16:46 ago) – Posting: # 11129
Views: 9,373

Ho John,

❝ My answers were often like "What can I do if your formulation looks like poop"

With diplomatic skills like that I imagine you might have had an ultra short half-life in the pharma industry

Of course you are right. With OIPs we sometimes see things like
T/R for Cmax=140%
T/R for AUCt=85%

-and company big wigs expect their formulation staff to come up with quickfixes.

These things are formulations where there are really no well-described pharmaceutical technologies available to tweak the two independently such as is the case with many SODFs. Poop indeed.

Complete thread:

• Sample size vasup 2013-07-29 08:37 
  • Sample size ElMaestro 2013-07-29 10:00
  • Sample size jag009 2013-07-29 15:57
  • Overpowering Helmut 2013-07-30 15:51
    • Overpowering ElMaestro 2013-07-30 16:37
      • Overpowering jag009 2013-07-30 16:45
        • OverpoweringElMaestro 2013-07-30 16:51
          • Overpowering jag009 2013-08-01 20:08
            • Overpowering kumarnaidu 2013-09-02 12:22
              • Conservative study planning Helmut 2013-09-02 12:42
                • Conservative study planning kumarnaidu 2013-09-02 14:36
                  • Conservative study planning Ohlbe 2013-09-02 18:44
                • confidence limit of the CV Jay 2013-09-06 13:55
                  • CL of CV Helmut 2013-09-06 15:02
                    • CL of CV Jay 2013-09-06 15:21
                      • CL of CV Helmut 2013-09-06 15:42
                        • PE consideration Jay 2013-09-11 11:02
                          • PE consideration Dr_Dan 2013-09-11 12:07
                            • PE consideration Jay 2013-09-11 13:09
                            • PE consideration kumarnaidu 2013-09-11 13:22
                              • Sockpuppet? Helmut 2013-09-11 14:13
                              • PE consideration kumarnaidu 2013-09-12 13:04