Abstract

Hypothyroidism is a common disease that needs to be closely treated, in order to reduce adverse symptoms and pathophysiological effects. For thyroid hormone replacement is preferred a therapy with a synthetic form of thyroxine (levothyroxine), a drug recognized by its Narrow Therapeutic Index. Generic levothyroxine can be an economic alternative for Hypothyroidism treatment. However, bioequivalence studies with levothyroxine are considered controversial. The aim of this review is to discuss aspects related to bioequivalence and biowaiver studies for levothyroxine considering the point of view of various regulatory agencies worldwide. Also, alternative strategies are proposed to perform bioequivalence with this drug.

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