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Dear all,
I am very much thankful if some one explain or clarify about the
following query
Can we include time deviation in collection of predose (before dosing
of drug) blood sample in PK analysis
Will it affect AUC?
Thanks
Sujatha
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Dear Ms. Sujatha,
> Can we include time deviation in collection of predose (before dosing
of drug) blood sample in PK analysis
Normally pre-dose samples are collected before 30 minutes or 60
minutes, as mentioned in the protocol. If it is fed study, it is
better to collect the blood samples before all subjects are sent for
high calorie breakfast.
It is enough to mention the exact time in the raw data. It all
depends on the protocol and / or your SOP.
> Will it affect AUC?
As for PK analysis, AUC is calculated from time zero to infinity/ time
t of last
sampling time. Here time zero is taken as the dosing time. Hence
the deviation in pre-dose deviation will not have any influence in AUC
Other members of the group can also send their opinion
T.R.Yegnaraman,
Manager-QA,
Azidus Laboratories Limited,
CRO division,
23, School Road,
Ratnamangalam
Vandalur-Kelambakkam Road,
chennai-600 048
India
mail : ryraman2661.-at-.yahoo.co.in, yegnaraman.aaa.azidus.com
www.azidus.com
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The following message was posted to: PharmPK
Hi Sujatha,
When estimating AUC, your zero time point, i.e. the time point you start
your calculations, is the time of administration of the drug. Deviations
in sampling before this time will not affect your AUC estimation.
Toufigh
Toufigh Gordi, Ph.D.
Associate Director, Pharmacokinetics
Depomed, Inc
1360 O'Brien Drive, Menlo Park, CA 94025
tgordi.-a-.Depomedinc.com
http://www.depomedinc.com
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The following message was posted to: PharmPK
Dear Sujatha,
In practice the time point deviations are protocol driven activities.
Generally for pre-dose, a deviation of 1 hour is allowed and for other
in-house collection a deviation of 2 minutes is allowed in clinical
situations. In my view, if there are no pre-dose concentrations (in all
periods), then putting time point deviations for pre-dose especially for
orally administered drugs, should not affect AUC.
Other thoughts from the experts!
Regards
Dr. Tausif Ahmed
Ranbaxy Labs Ltd
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The following message was posted to: PharmPK
> Dear Sujatha,
I think no need to include predose time and will not be the part of AUC
Zafar
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