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The following message was posted to: PharmPK
Good day every one.
Has anybody experience handling data obtained from a subject who
suffered vomiting within 2 times of Tmax period following ingestion of
an extended release product & acceptance of the data from US FDA
perspective.
Thanks in advance
Isra
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The following message was posted to: PharmPK
Hi Isra,
As per the FDA guidance, "Guidance for Industry, Bioavailability and
Bioequivalence Studies for Orally Administered Drug Products --
General Considerations. U.S. Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(CDER), March 2003":
"Data deletion due to vomiting:
* We recommend that data from subjects who experience emesis during
the course of a BE study for immediate-release products be deleted
from statistical analysis if vomiting occurs at or before 2 times
median Tmax. In the case of modified-release products, the data from
subjects who experience emesis any time during the labeled dosing
interval can be deleted."
I've always seen data excluded from the statistical analysis if the
subject vomits at any time during the labeled dosing interval, if it
is an extended release product. I haven't seen 2 times median Tmax used.
Hope this helps,
-Dave
--
David Dubins, Ph.D., B.Eng.
Global Bioequivalence Consulting
Assistant Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
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