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Dear All,
Can any body help me regarding the designing the BE study based on the
Urine excretion data, particularly collection of the samples, design
of the study, statistics involved and the interpretation/ conclusion.
As there is very little information available in the guidelines (e.g
FDA, EMEA, Canadian etc)
Thanks in advance.
Ratnakar
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The following message was posted to: PharmPK
Try the FDA guidance for potassium chloride:
http://www.fda.gov/Cder/Guidance/5523fnl.pdf
Best, -Dave
--
David Dubins, Ph.D., B.Eng.
Global Bioequivalence Consulting
Assistant Professor, Leslie Dan Faculty of Pharmacy
University of Toronto
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