Bioequivalence and Bioavailability Forum

Fed study [Regulatives / Guidelines]

posted by dixit – India, 2012-09-24 12:35 (5025 d 23:12 ago) – Posting: # 9242
Views: 3,788

Dear All,

As per the EMEA requirement, fed study for a molecule is conducted only when SPC states that the pharmacokinetics is affected in fed conditions/ or by food. How to decide to conduct a fed study if the pharmacology states as below.

Mobiflex is rapidly and completely absorbed as unchanged drug. Concomitant food reduces the rate, but not the extent, of absorption of Mobiflex.
Regards,

DIXIT.

Complete thread:

• Fed studydixit 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 study Dr_Dan 2012-10-01 10:52