ASSESSING EQUIVALENCE OF INHALED DRUGS

The move to disease management has led to an increase in the practice of drug or formulation substitution on the basis of equivalence. Well established guidelines are available for judging equivalence between o ral, but not inhaled, formulations. This article describes the criteri a by which equivalence can be assessed and concludes that although tra ditional issues such as adequate sample size are important, studies al so need to be designed in such a way as to avoid the possibility of fa lsely concluding clinical equivalence.