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The following message was posted to: PharmPK
Hi
I want to comapre a single dose oral bioavailability study
comparing oral route of administration and IV infusion. The dose
is 5 mg. Incase of IV infusion it has to be given for a period of
2hours. I need your help to decide on sample time point
collection. For oral administration it is not a problem but incase
of IV infusion should i start collecting the blood sample from
0.0,0.25,0.5,0.75,1.0hr etc.during the dug administeration via IV
infusion or should i collect the blood sample after waiting for
completion of infusion time of 2 hours.
Thanks in advance.
Ashish Jain
HEad-Bioanalytical Research
Wellquest Clinical Research
GPK MArg, Off Worli Naka
Lower Parel, Mumbai
Tel 91 22 5660 856/67 Ext 233
[I think you should use a similar sampling scheme for both routes given
the 2 hour infusion - db]
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The following message was posted to: PharmPK
Dear Ashish,
I think you can have the same sampling schedule for both oral and iv
infusion (after 2 h infusion). Make sure you have the correct infusion
data to do the data modelling for PK-parameters.
Good luck
Manoj
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The following message was posted to: PharmPK
hi Ashish
you could sample as 0, 0.5, 1 hr 2 hr and then sample during the
distribution phase and elimination phase. it is good to have at least 4
points in the distributive and 4 points during the elimination phase.
The
sampling frequency would be determined by the sample volume u like to
use
for ur assay. if low volumes (few hundred µls) are required for the
assay
then multiple blood volumes could be removed. the basic idea of
infusing the
drug is to obtain a good estimate of ur Conc at time zero. Samples
during ur
infusion period would ensure that steady state is acheived.
hope this helps
best of luck
manish
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