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Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One? (2019)
Journal Article
Concordet, D., Gandia, P., Montastruc, J., Bousquet-Mélou, A., Lees, P., Ferran, A. A., & Toutain, P. (2019). Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?. Clinical Pharmacokinetics, 59, 1-5. https://doi.org/10.1007/s40262-019-00812-x

At the request of French Regulatory Authorities, a new formulation of Levothyrox® was licensed in France in 2017, with the objective of avoiding the stability deficiencies of an existing licensed formulation. Before launching the new formulation, an... Read More about Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?.