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Methodological standards for assessing therapeutic equivalence.

B Kirshner
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Abstract

This paper reviews issues related to defining and demonstrating therapeutic equivalence. A set of guidelines are proposed to critically review clinical trials to determine whether there is sufficient evidence to conclude that an experimental therapy is therapeutically equivalent to a standard one. These guidelines include criteria for assessing whether imprecision pertaining to the measurement of outcomes impinges on the validity of an equivalence test.

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Clinical Trials as TopicHealth Planning GuidelinesHumansTherapeutic EquivalencyJournal ArticleReview

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B Kirshner. 1991. Methodological standards for assessing therapeutic equivalence.. https://doi.org/10.1016/0895-4356(91)90139-z

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