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The following message was posted to: PharmPK
Dear all,
I have one question regarding study procedure in BE studies.
Is it important due to PK reasons that subjects need to be in sitting or
standing position first three hours after a drug administration?
And, why is important when subject is not feeling well to lie down on
his right side?
My additional question is amount of administered water, in FDA guideline
the amount of 240 ml is recommended, what are your experiences with EU
submission?
Thx in advance,
Lidija
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Dear Lidija,
1. Subjects need to be in sitting or ambulatory (with not much
exercise) at least for first two hours post dose. Its a standard
practice (lying down has its effects on gastric emptying). You may
like to check with FDA/ EMEA for special conditions or exceptions -
e.g. for ropinirole, subjects are required to be supine after dosing
to avoid postural hypotension. Its a safety measure. This can be done
by writing to the respective regulatory body.
2. Subjects are made to lie on the right side owing to the anatomy of
the stomach. Lying on right side will facliltate gastric emptying. I
will also quote "However, gastric emptying of the aqueous phase of
the fat/aqueous meal (B) was considerably slower when lying on the
left compared to the right side...." from webpage http://
www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2982.1997.d01-6.x)
3. For EU, 8 ounces or 240 ml water should be fine.
Regards,
Dr. Gagandeep Singh
Manager - Senior Consultant, Lifesciences
Domain Consulting Group
Cognizant Technology Solutions
VNET: 29114
CTS - Mumbai ext: 2504
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The following message was posted to: PharmPK
Dear Lidija!
> My additional question is amount of administered water, in FDA
guideline
> the amount of 240 ml is recommended, what are your experiences
with EU
> submission?
The European Note for Guidance suggests 150 ml.
For details (and also recommendations of other countries) see:
http://forum.bebac.at/mix_entry.php?id=9
Best regards,
Helmut
--
Ing. Helmut SchA\0x00tz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
tel/fax +43 1 2311746
e-mail helmut.schuetz.-at-.bebac.at
web http://bebac.at
forum http://forum.bebac.at
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