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Would appreciate if some one can direct me to a good article or text book on application of reference scaled study design for bio equivalence testing and relevant statistical calculations for US FDA application.
Thanks,
Paul
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A good one from both, educational and training perspective, is "Bioequivalence and statistics in clinical pharmacology", written by Scott Patterson and Byron Jones, 2006 (Web site at: www.crcpress.com).
Regards,
Dimiter T.
--
Dimiter Terziivanov, MD,PhD,DSc, Professor
Pharmacology and Clinical Pharmacology
SOFIA UNIVERSITY "ST. KLIMENT OHRIDSKI"
FACULTY OF MEDICINE
1 Koziak str.
1407 Sofia, BULGARIA
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