Bioequivalence and Bioavailability Forum • Fed study

Fed study [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2012-10-01 12:52 (5020 d 16:36 ago) – Posting: # 9286
Views: 3,015

Dear Sam

❝ I am totally agreed with the recommendation of stated by Torn by EMEA for the fed study "For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions".

❝ So as per my opinion you have to perform both the fasting and fed study.

IMHO there is a contradiction, right?
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Fed study dixit 2012-09-24 10:35
- Fed study ElMaestro 2012-09-24 10:49
- Fed study The Outlaw Torn 2012-09-25 07:39
  - Fed study Dr_Dan 2012-09-25 11:11
- Fed study sam 2012-09-29 06:21
  - Fed studyDr_Dan 2012-10-01 10:52