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Is anyone aware of a reference(s) that would be useful in providing
information on how to design an animal bioequivalence study for an i.m.
injected compound in order to get a rough idea of test-reference
comparison
before conducting a pilot clinical trial? Information such as what
animal
to use, where to do the injection, how much variability to expect, etc.
would be of great help.
Kind Regards,
Arlin Blood, PhD
Radiant Research - Honolulu
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Arlin,
The utility of animal models for bioequivalence for extrapolation to
humans is dubious. There are many physiological issues that make
interpretation of such models difficult. I would think that a small
pilot study in healthy volunteers would yield more useful information.
Garry
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)