Back to the Top
Dear All,
I intend to develop a pharmacokinetic assay with TRIMEBUTINE (single
dose and oral administration), but we do not know if this drug has
any interaction with meal. Labeling of some products suggest that
administration may be made with food, but there is not any reference
in literature that describes a better bioavailability when it is take
in fed condiction compared with fasting.
So, I wondered if anyone could provide me some enlight about this
issue, because we need to choose between fed or fasting
pharmacokinetic study (bioequivalence) and justify our decision.
Regards,
Daniel Rossi de Campos, M.Sc
Brazil
Back to the Top
The following message was posted to: PharmPK
So, umm, do a PK study in both fed AND fasting conditions....?
Back to the Top
Dear Daniel
You can refer back o the FDA guideline:
Guidance for Industry Food-Effect Bioavailability and Fed
Bioequivalence Studies
you will find all answers related to BE food effect and fed studies.
you can
find it in www.fda.gov
hope this helps
regards
Isra' Admour, M.Sc Pharm
Regualtory Affairs Director
International Pharmaceutical Research Center (IPRC)
Tel: +962-6-5627651/52/48 (ext. 225)
PO Box 963166, Amman11196, Jordan
www.iprc.com.jo
Back to the Top
If the drug is already in the market, you are just looking at
relative bioavailability. Since the drug is already given with food,
fed will be your reference.
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)