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Theta
Hat Statistical Consultants LLC.
Theta Hat Statistical Consultants LLC.
3723 Birchmere Ct.
Owings Mills, MD 21117
Phone: 443-562-5952
bruce.thompson@thetahat.net
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Who are we?
Counting Processes
Survival Analysis
Longitudinal Data
Population Bioequivalence
Sample Size
Comparing Two PK Curves
B
ioequivalence analysis is used to assess the expected
in vivo
biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. We specialize in PBE analysis based on the guidance prepared by the FDA. Until now, this has mainly consisted of looking at spray characteristics of two treatments. More recently we have expanded our capabilities to analyze any set of digital signatures collected as data from electronic measurements. This is done using the Earth Movers Distance (EMD) metric.
Population Bioequivalence Analysis