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» » 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.
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 designxtianbadillo 2018-03-16 15:26
- Diclofenac SR fast or fed state study design Norah 2018-03-14 11:55
- 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
- Homework Helmut 2018-02-20 12:45
Ing. Helmut Schütz