Bioequivalence and Bioavailability Forum • Any experiences?

Any experiences? [Design Issues]

posted by nobody – 2014-10-20 16:21 (4267 d 23:37 ago) – Posting: # 13757
Views: 28,160

❝ But in renal/hepatic impaired patients we are talking about clearance. That’s the drug, not the formulation.

Not necessarily, might also be on absorption level... I think pathophysiological alterations might include active as well as passive absorption mechanisms as well as presystemic metabolism (both phase I and II)

Οὐδείς

PS: Regarding LZB and "healthy volunteers": prospective trials is one piece of cake, clinical practice (including therapeutic drug monitoring) and e.g. epileptics/immunosuppressants a completely other...

PPS: Finding BE-failures in clinical practice is almost like studying carcinogenicity of a drug from post-marketing surveillance data, i.e. virtually impossible. Maybe for an analgesic you would be able to detect a large difference in Cmax, but how about antihypertensives or even lipid lowering drugs in "primary prevention" (one of my favorite indications).

—
Kindest regards, nobody

Complete thread:

Subject selection ele2008 2014-10-16 05:06
- Genotyping in BE Helmut 2014-10-16 15:04
  - Genotyping in BE ele2008 2014-10-16 16:18
    - Genotyping in BE nobody 2014-10-16 17:43
      - Genotyping in BE Helmut 2014-10-16 18:13
        
        Genotyping in BE nobody 2014-10-16 18:24
        
        Any experiences? Helmut 2014-10-17 19:30
        
        Any experiences? nobody 2014-10-17 20:04
        
        Any experiences? Helmut 2014-10-18 15:04
        
        Any experiences? nobody 2014-10-20 08:06
        
        Any experiences? Helmut 2014-10-20 13:00
        
        Any experiences?nobody 2014-10-20 14:21
- Subject selection ele2008 2014-10-23 05:25
  - Subject selection ele2008 2014-10-23 16:47
    - Subject selection ElMaestro 2014-10-23 17:25
      - Subject selection nobody 2014-10-23 17:53
    - Editing posts Helmut 2014-10-23 17:54
    - ♀ on a mission? Helmut 2014-10-23 19:50