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Hi All,
As my knowledge, in bioequivalence studies it is recommended a
standardized diet for volunteers (approx. 2000 kcal.)
How much can this factor influence the PK profile of the drug? Is the
caloric intake so important to control in this kind of studies?
Thank you,
Vlase Laurian
Univ. of Med. & Pharm. "I. Hatieganu"
Cluj-Napoca
Vlase Laurian Univ. Med. & Pharmacy "I. Hatieganu" Dept. of
Pharmaceutical Technology and Biopharmaceutics Cluj-Napoca Romania
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The following message was posted to: PharmPK
Dear Vlase,
There are certainly examples where the diet had significant influence
on the
Pk profile- especially the amount of fat in the diet can be a major
factor.
However, there is another major reason for a caloric restriction.
That is
that some liver enzymes are very suspectible to a relatively high calory
diet. This may result in difficult to explain disturbances in liver
function
(ALAT and ASAT generally), which may lead to the suggestion that the
drug
involved can cause hepatotoxicity. Hence are studies in volunteers
usually
performed with a restriction in caloric intake.
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