Open AccessGeneric - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues
Author(s) -
Roberto Nardi,
Marco Masina,
G Cioni,
Paolo Leandri,
Paola Zuccheri
Publication year - 2014
Publication title -
italian journal of medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.134
H-Index - 10
eISSN - 1877-9352
pISSN - 1877-9344
DOI - 10.4081/itjm.2014.398
Subject(s) - bioequivalence , medicine , equivalence (formal languages) , distrust , confusion , pharmacology , clinical trial , bioavailability , intensive care medicine , psychotherapist , mathematics , psychology , psychoanalysis , discrete mathematics
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