Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-14 14:03 (2604 d 03:37 ago) – Posting: # 18539
Views: 2,403

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,667 registered users;
19 visitors (0 registered, 19 guests [including 10 identified bots]).
Forum time: 18:40 CEST (Europe/Vienna)

Garbage in, garbage out.
It’s very very simple.    Anders Fuglsang

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5