Bioequivalence and Bioavailability Forum • Truncted AUC, low variability

Truncted AUC, low variability [Design Issues]

posted by jag009 – NJ, 2017-08-18 01:50 (2440 d 07:05 ago) – Posting: # 17707
Views: 8,347

Hi Helmut,

❝ It is an open question what a “long half-life drug” is. An numerous conferences both the FDA and the EMA refused to give a definition. Only the Canadian HPFB formerly stated t_½ ≥24 hours.

So far no problems for me w FDA. I've ran 6 - 10 of these with t1/2=24 and up (okay, 3 drugs w mean 24 hrs.)

John

Complete thread:

long half life drug bioequivalence study design ssussu 2017-08-16 11:45
- long half life drug bioequivalence study design ElMaestro 2017-08-16 12:53
  - long half life drug bioequivalence study design ssussu 2017-08-17 10:18
- Truncted AUC, low variability Helmut 2017-08-16 14:18
  - Truncted AUC, or AUCinf, which one ssussu 2017-08-17 10:15
    - Truncted AUC, or AUCinf, which one ElMaestro 2017-08-17 10:47
      - Truncted AUC, or AUCinf, which one ssussu 2017-08-18 07:13
  - Truncted AUC, low variabilityjag009 2017-08-17 23:50