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Comment
. 2020 Feb;59(2):277-279.
doi: 10.1007/s40262-019-00851-4.

Authors' Reply to Nicolas: "Why Were More than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"

Didier Concordet  1 , Peggy Gandia  1 , Jean-Louis Montastruc  2 , Alain Bousquet-Mélou  1 , Peter Lees  3 , Aude A Ferran  1 , Pierre-Louis Toutain  4   5
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Comment

Authors' Reply to Nicolas: "Why Were More than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"

Didier Concordet et al. Clin Pharmacokinet. 2020 Feb.
No abstract available

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Conflict of interest statement

Didier Concordet, Peggy Gandia, Jean-Louis Montastruc, Alain Bousquet-Mélou, Peter Lees, Aude A. Ferran, and Pierre-Louis Toutain have no conflicts of interest that are directly relevant to the contents of this reply.

Comment on

References

    1. Nicolas P. Comment on: “Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of levothyroxine with an old one?”. Clin Pharmacokinet. 2019 doi: 10.1007/s40262-019-00812-x. - DOI - PubMed
    1. Concordet D, Gandia P, Montastruc J-L, Bousquet-Mélou A, Lees P, Ferran AA, et al. Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of levothyroxine with an old one? Clin Pharmacokinet. 2019 doi: 10.1007/s40262-019-00812-x. - DOI - PMC - PubMed
    1. Concordet D, Gandia P, Montastruc J-L, Bousquet-Mélou A, Lees P, Ferran A, et al. Levothyrox® new and old formulations: are they switchable for millions of patients? Clin Pharmacokinet. 2019;58:827–833. doi: 10.1007/s40262-019-00747-3. - DOI - PMC - PubMed
    1. Morais JAG, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010;106(3):221–225. doi: 10.1111/j.1742-7843.2009.00518.x. - DOI - PubMed
    1. Anonymous. Draft guidance on levothyroxine sodium. Food and Drug Administration; 2018: p. 2. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat.... Accessed 4 Oct 2019.

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