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I understand that subject-outlier is not an unusual situation during
any bio-equivalence trials. However, Can somebody point out how many
outliers (%) during a clinical trial would jeopardize the whole study?
Thanks.
Ilkay Talu
R&D Project Engineer
Abdi Ibrahim Pharmaceuticals Inc.
Tel: (90)-212-623 1960 ext:416
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The following message was posted to: PharmPK
Dear Ilkay
The answer for your question will be depend on the samples size, the
power
of the study as well as the intrasubject variability of your drug
product..
I have seen 36 subject 2-way crossover study failed due to one outlier
subject when the power was set to 80% and the intra subject %CV is > 26%
and difference was +/-10%.
Hope this helps
Kindly
Sibel Demirbas Ucpinar, PhD.
Manager, Biopharmaceutics
Watson Laboratories, Inc.
A Subsidiary of Watson Pharmaceuticals, Inc.
311 Bonnie Circle
Corona, CA 92880
Phone: 951-493-4047
Fax: 951-493-5441
Cell: 951-314-8390
Email: "Sibel Ucpinar"
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