The practical use of equivalent drugsIn the clinical practice, several aspects associated with the use of equivalent drugs need to be considered (Table 1).
Determination of bioequivalence by means of studies in healthy volunteers as a single doseBioequivalence studies are performed on healthy volunteers. It is conventionally accepted that a similar bioavailability found in these people is a solid proof of a similar bioavailability in sick people! This model applied in vivo on healthy volunteers is considered adequate in most instances to detect formulation differences and to allow extrapolation of results to populations for which the reference medicinal product is approved (elderly, children, patients with renal or liver impairment, etc.). Another critical aspect of bioequivalence research is that it is recognized on the basis of studies carried out on a single dose, despite in clinical practice these drugs are administered in repeated doses to chronic patients. 1 In this respect, one might wonder whether single-dose studies on a limited number of healthy volunteers can adequately mirror the use of drugs in real life and whether the same results apply the most common groups of patients?. 2 According to some, in certain cases bioavailability tests need to be carried out on real patients. The question is not so much whether patients are different from volunteers, but rather whether, and when, these differences could cause two products that seem bioequivalent in normals become bioinequivalent in a clinical setting. A literature review aimed to study these factors in real patients has shown that only very few relevant publications are available on this topic. Moreover, involving patients instead of healthy volunteers would invariably increase inter-subject variability and possibly intra-subject variability as well. 3