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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?

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Published in 2019 at "Clinical Pharmacokinetics"

DOI: 10.1007/s40262-019-00812-x

Abstract: 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… read more here.

Keywords: bioequivalence; new formulation; formulation; levothyroxine ... See more keywords