Emphasizing the role of good statistical practices (GSP) in drug
research and formulation, this book outlines important statistics
applications for each stage of pharmaceutical development to ensure
the valid design, analysis, and assessment of drug products under
investigation and establish the safety and efficacy of
pharmaceutical compounds. Coverage include statistical techniques
for assay validation and evaluation of drug performance
characteristics, testing population/individual bioequivalence and
in vitro bioequivalence according to the most recent FDA
guidelines, basic considerations for the design and analysis of
therapeutic equivalence and noninferiority trials.
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