Bioequivalence and Bioavailability Forum • Prolonged release: washout

Prolonged release: washout [Design Issues]

posted by mittyri – Russia, 2014-12-29 09:32 (4191 d 11:12 ago) – Posting: # 14197
Views: 9,112

Hi Angus,

Sorry, the presented data is found in Public Assessment Report, I haven't access to the individual data. So I'm going to use the maximum of presented Thalf (8h) and mean Tmax for sampling time calculation, as you wrote in the example.

What about washout period calculation?
I can conclude from the presented data that 5 halflives are not enough for washout. Are there any rules for washout period calculation for Controlled Release Formulations?

—
Kind regards,
Mittyri

Complete thread:

Prolonged release: sampling time and washout calculation mittyri 2014-12-21 17:52
- Prolonged release: sampling time and washout calculation ElMaestro 2014-12-21 20:38
- Prolonged release: sampling time and washout calculation AngusMcLean 2014-12-21 23:00
- Predominant t½ Helmut 2014-12-22 02:43
  - Prolonged release: updated data mittyri 2014-12-28 16:37
    - Prolonged release: updated data ElMaestro 2014-12-28 17:23
      - Prolonged release: updated data mittyri 2014-12-29 07:57
    - Prolonged release: updated data AngusMcLean 2014-12-29 00:00
      - Prolonged release: washoutmittyri 2014-12-29 08:32
        
        Prolonged release: washout AngusMcLean 2014-12-29 15:29
        
        Prolonged release: thanks mittyri 2014-12-29 21:11