Bioequivalence and Bioavailability Forum • Diclofenac SR fast or fed state study design

Diclofenac SR fast or fed state study design [Design Issues]

posted by xtianbadillo – Mexico, 2018-03-16 16:26 (2500 d 04:43 ago) – Posting: # 18562
Views: 6,255

❝ ❝ Recommended studies: 2 studies : does it mean that both should be perofrmed??

Yes, you have to perform both studies. There are some recommendations.

1) Two cross-over, One study should be conducted under fasting conditions and the other after-meal intake at a specific time before the administration of the treatment.

2) A study cross-over, with four periods, with four sequences for four treatments. Both the test medication and the reference medicine should be evaluated under fasting conditions and after food intake at a specific time before the administration of the treatment.

Complete thread:

Diclofenac SR fast or fed state study design Norah 2018-02-20 09:14 [Design Issues]
- Homework Helmut 2018-02-20 12:45
  - Homework Norah 2018-03-09 16:45
- Diclofenac SR fast or fed state study design xtianbadillo 2018-03-09 19:31
  - Diclofenac SR fast or fed state study design Norah 2018-03-14 11:55
    - Diclofenac SR fast or fed state study designxtianbadillo 2018-03-16 15:26
      - Diclofenac SR fast or fed state study design Norah 2018-04-02 12:22
- Diclofenac SR fast or fed state study design nobody 2018-04-02 14:29
  - Diclofenac SR fast or fed state study design Norah 2018-04-02 15:05
- Diclofenac SR fast or fed state study design balakotu 2018-04-13 08:22