TY - JOUR AU - Nardi, Roberto AU - Masina, Marco AU - Cioni, Giorgio AU - Leandri, Paolo AU - Zuccheri, Paola PY - 2014/05/08 Y2 - 2024/03/29 TI - Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues JF - Italian Journal of Medicine JA - Ital J Med VL - 8 IS - 2 SE - Reviews DO - 10.4081/itjm.2014.398 UR - https://www.italjmed.org/ijm/article/view/itjm.2014.398 SP - 80-87 AB - 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; <em>in vitro</em> studies) is also included. ER -