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Hi all
I am presently working on ANDA submission for Immediate Release Oral
solid dosage form. I need a clarification regarding BE studies.
Should I do both fasting and fed studies
The Guidelines ́BA and BE studies , General considerationsî FDA
guidelines talks about Fed study only under Modified release drug.
If suppose the innovator has done fed studies, is it compulsory that I
should also do Fed study though it is not mentioned anywhere in the
guideline.
Please Clarify my query
Thanks and Best Regards
Meera.K
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Dear Dr. meera
If there are reports in the literature about the effect of food on the
PK of drug concerned then you have to do the fed study. Moreover if the
drug is indicated to be taken as empty stomach then there is no need to
do the fed study.
For more details please refer FDA guidelined for fed BA/BE studies
regards
Tausif Ahmed
Doctorate student, Dept. of Pharmaceutical Medicine
Ranbaxy Clinical Pharmacology Unit
Majedia Hospital, Hamdard univ.
New Delhi, India
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The following message was posted to: PharmPK
Sir,
The guidance document in question is the "Bioavailability and Bioequivalence
Studies for Orally Administered Drug Products - General Considerations
Guidance" , it is more of a points to consider document rather than an
unified all encompassing guidance for drug development. On the same web
page you will find under Biopharmaceutics Guidance documents the
"Food-Effect Bioavailability and Fed Bioequivalence Studies Guidance" which
gives clear guidance on this issue for both NDA's and ANDA's both IR and MR.
In the case of two guidance documents, one being general and one specific
you should be guided by the more relevant document.
E. Dennis Bashaw, Pharm.D.
Team Leader
Division of Pharmacuetical Evluation-III
US FDA
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