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The following message was posted to: PharmPK
Dear All,
receive my best wishes.
I have a doubt regarding liquid / water restriction in bioequivalence
studies. We want to conduct a study where only urine will be collected
from subjects (after administration of medicine) for PK analysis.
According to guideline liquid / water intake should be standardized
during the study.
After dosing to subjects we are planning to standardize liquid intake
till two times of the Tmax i.e. giving a fixed amount of water in
regular one hour interval till two times (in hour) that of Tmax. Is this
correct or do we need to standardised liquid / water intake during whole
duration of the study for flawless PK analysis?
Regards,
Sumanta.
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The following message was posted to: PharmPK
hi all
What you are planning to do is right as long as the intake quantity
of water is standardize preferably up to two half-life of your drug
elimination phase,because it is will known that urine flow might be
effect the elemination if it is widly varabile. Another factor you
should consider is sabilizing the urine PH if your drug is highly
ionized
Hoping this will help
Good luck.
Khalil I M Al-Khamis, Ph.D
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The following message was posted to: PharmPK
The standadization simply means all the human volunteers or Animals
should be given equal volumes of water. For instance you can give all
the volunteers 500 mls of previously boiled and cool water.
Why don't you take blood samples cause there is usually a lot of
experimental errors with urine analysis?
s.o.o
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