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Dear Sir,
I am Dipak Shinde and I have some questions regarding
bioequivalance study.
I would be thankful to you if you try to help me out. Below the
questions are mentioned
1. Why we keep water restriction before and after dosing?
2. Why we maintain posture restriction?
3. Why we keep subjects under fasting condition atleast for 10 to 12
hrs before dosing?
Hoping for your kind cooperation.
Thanking you.
Regards,
Dipak Shinde
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The following message was posted to: PharmPK
Dear Dipak,
All your three questions have only one answer. All these restrictions
are
meant for standardizing the physiology of the subjects to the extent
possible, even though it won't be of 100%. Because if we don't maintain
these restrictions, there will be huge difference among the subjects,
since
all these parameters can influence the drug absorption and
metabolism, like
presence of water and food substance can alter the gastric physiology
and
similarly uncontrolled physical motility can influence the hemodynamics
which in turn can again influence the drug pharmacokinetics. That's the
reason why we impose restrictions atleast during the initial crucial
hours
after drug administration.
Hope this clarifies.
Regards
Dr. M. Joseph
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