Back to the Top
The following message was posted to: PharmPK
Dear All,
I am intending to work on a project which involves Bioequivalence
study for Paracetamol Sustained release .I am in a delima whether to
conduct the study both in fasting and fed condition or only in fasting
condition.
I have refered to EMEA, TGA, FDA guidelines for conducting BA/BE study
for Modified release dosage form.
TGA guideline (EMEA guide line adopted by TGA CPMP/EWP/280/96)
indicated in the page no 11 of 11 that if the proposed product
having similar marketed form already approved then the pharmacokinetic
requirements will be based on the effect of food (based on
literature).
For evidence of the effect of the food I searched the literature
(Pubmed) and found some articles which clearly demonstrate the effect
of food on absorption of paracetamol.
1. Divoll M et al., Effect of food on acetaminophen absorption in
young and elderly subjects., Clin Pharmacol.1982 Nov-Dec; 22 (11-12):
517-6
2. Forrest JA et al., Clinical Pharmacokinetics of paracetomol Clin
Pharmacokinetics., 1982 Mar Apr; 7 (2) : 93-107
Further to that I also searched FDA site for the approved prolonged
release paracetamol and found some approved ANDA which clearly says
the required studies (Fasting, Non fasting and Multiple dose studies).
In the light all the above I request further view on this subject so
that accordingly I can plan for BE studies for Paracetamol SR.your
early response is highly appreciated.
Thanks & Regards,
PreethiMahesh
Msc., Clinical Research.
Bangalore.
Back to the Top
The following message was posted to: PharmPK
Hi Preethi
According to me, if you have made SR formulation for a drug which have
earlier shown food effect in vaious studies, then you have to do fasting
and fed studies.
As you must be knowing the case of theophylline.
Regards
Priyadeep
Back to the Top
Dear PreethiMahesh,
Can you please let me know where Paracetamol
Sustained release formulation is available. I have gone through USFDA
site but i did not get any reference of SR formulation of paracetamol.
Please clarify.
Regards,
Tushar Nahata
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Paracetamol BE study" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)