Homework [Regulatives / Guidelines]
Hi Norah,
Please do your homework first (see also this post #3). According to the EMA’s immediate release BE GL, Section 4.1.4 Study conduct, Fasting or fed conditions:
If you are dealing with modified release products – even if the SmPC of the reference recommends intake under fed conditions – additionally a study in fasting state has to be performed. For details see the EMA’s MR GL, Appendix IV. BTW, it is a good idea to perform the study in fed conditions first.
❝ is there any exemption for studies under fasting condition, if the fed study shoes bioequivalence of both medications??
Please do your homework first (see also this post #3). According to the EMA’s immediate release BE GL, Section 4.1.4 Study conduct, Fasting or fed conditions:
For products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions.
Only in this case it is not necessary to perform a study in fasting state.If you are dealing with modified release products – even if the SmPC of the reference recommends intake under fed conditions – additionally a study in fasting state has to be performed. For details see the EMA’s MR GL, Appendix IV. BTW, it is a good idea to perform the study in fed conditions first.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- fed or fasting conditions studies Norah 2018-03-14 11:57 [Regulatives / Guidelines]
- HomeworkHelmut 2018-03-14 13:03
- Homework Norah 2018-03-14 14:15
- HomeworkHelmut 2018-03-14 13:03