Maintaining the same practical viewpoint as its bestselling predecessors, this third edition presents a comprehensive, unified summary of the vast and continually growing literature and research activities in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and analyzing bioequivalence studies. The preeminent authors cover the assessment of food effect on bioequivalence, bioequivalence for drugs with local action, the qualitative determination of pharmaceutical equivalence, bioequivalence for biological products, medical devices, the use of genomic information in assessing bioequivalence, and ethnical and gender differences in assessing bioequivalence.
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