Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

  • Roberto Nardi | nardidoc48@gmail.com UOC Medicina Interna, AUSL Bologna, Ospedale Maggiore, Bologna, Italy.
  • Marco Masina UOC Geriatria, AUSL Bologna, Ospedale di Bentivoglio (BO), Italy.
  • Giorgio Cioni UOC Medicina Interna, AUSL di Modena, Pavullo nel Frignano (MO), Italy.
  • Paolo Leandri UOC Medicina Interna, AUSL Bologna, Ospedale Maggiore, Bologna, Italy.
  • Paola Zuccheri Farmacia Clinica H e Continuità H/T, AUSL Bologna, Ospedale Maggiore, Bologna, Italy.

Abstract

Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability. A summary of the methods adopted to define bioequivalence (pharmacokinetic studies; pharmacodynamic studies; comparative clinical trials; in vitro studies) is also included.

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Published
2014-05-08
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Issue
Section
Reviews
Keywords:
generic drugs, equivalent drugs, drugs with expired patent, pharmacological issues, pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability, biowaivers.
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How to Cite
Nardi, R., Masina, M., Cioni, G., Leandri, P., & Zuccheri, P. (2014). Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues. Italian Journal of Medicine, 8(2), 80-87. https://doi.org/10.4081/itjm.2014.398