Bioequivalence and Bioavailability Forum • Overpowering

Overpowering [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-07-30 18:51 (4716 d 08:55 ago) – Posting: # 11129
Views: 9,379

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 :-D

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.

—
Pass or fail!
ElMaestro

Complete thread:

Sample size vasup 2013-07-29 08:37 [Regulatives / Guidelines]
- 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