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Statistical aspects of bioequivalence testing between two medicinal products

E Zintzaras1

  • 1Department of Biomathematics, School of Medicine, University of Thessaly, Larisa, Greece. zintza@med.uth.gr

European Journal of Drug Metabolism and Pharmacokinetics
|July 14, 2005
PubMed
Summary

This study explores bioequivalence study designs and statistical methods for comparing generic drugs to innovator products. It details how pharmacokinetic parameters like AUC and Cmax assess bioavailability and ensure drug product similarity.

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