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Dear All,
Do we need to use the same group of subjects for fast and fed BE
study? Since we need to draw about 250 ml of blood for each condition
from subject so the study period between fast and fed should be at
least 3 months if we use the same group of subject.
Best Regards,
Wichittra
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Not at all..
these would be two different studies with two different sets of
volunteers...
should have 2 different protocols also...
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre,
Village: Bhat, Dist: Gandhinagar - 382 428
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The following message was posted to: PharmPK
Dear Wichittra,
There is no requirement to do fasting and fed studies on same set of
volunteers. You can consider them as two different studies all
together and
plan accordingly.
Best Regards
Dr. M. Joseph
Lambda Therapeutics
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Wichittra,
It is noteworthy to consult European, USA, Canadian etc. Guidances
facing this problem. They explicitly state that you have to perform 2
different BE trials, in fasting and fed conditions, enrolling
different sets of subjects in case you need to save time. Otherwise,
you should wait at least 3 months in order to enrol the samr set of
volunteers.
Regards,
Dimiter Terziivanov
--
Dimiter Terziivanov, MD,PhD,DSc, Professor and
Head, Clinic of Clinical Pharmacology and Pharmacokinetics,
Univ Hosp "St. Ivan Rilski",
15 Acad. Ivan Geshov st, 1431 Sofia, Bulgaria
e-mail: dterziivanov.-a-.rilski.com; terziiv.aaa.yahoo.com
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The following message was posted to: PharmPK
dear,
it is not required to use the same group of subject in fast and fed
study.
regards,
paresh
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Dear Wichittra
It is not mandatory to use the same subjects for both fast and fed BE
study.
Also with sufficient gap between two studies i.e by maintaining 90
days in between the conditions you can go ahead with the same group of
volunteets/subjects.
Ramu
Apotex PVt Ltd.
Bangalore
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Dear Wichittra,
As already mentioned by the group members, you need not use the same
group of subjects for fast and fed subjects.
As per the blood withdrawal, there are instances where we have
withdrawn blood upto 450 mL from each subject in a BE study. This will
also depend on the duration of study. The decision on blood loss will
be decided by EC/IRB.
Regards
Dr. Tausif Ahmed
Senior Research Scientist
Metabolism and Pharmacokinetics
Ranbaxy Research Laboratories, India
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The following message was posted to: PharmPK
Dear wichittra
It is not mandatory to use same group of subjects for fasting and fed BE
studies. In one complete study blood withdrawal upto 450mL is acceptable
or one shall follow the EC/IRB guidelines for the same.
However, if you wish to continue the fasting and fed study in same
group, you need to have 84 days gap.
Regards
Anita
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