Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-14 14:03 (2262 d 14:45 ago) – Posting: # 18539
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Hi Norah,

❝ 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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