Authors’ Reply to Yu et al.: “Levothyrox® New and Old Formulations: Are They Switchable for Millions of Patients?”

Author:

Concordet Didier,Gandia Peggy,Montastruc Jean-Louis,Bousquet-Mélou Alain,Lees Peter,Ferran Aude A.,Toutain Pierre-LouisORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference15 articles.

1. Yu Y, Maliepaard M. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients?”. Clin Pharmacokinet. 2019. https://doi.org/10.1007/s40262-019-00850-5.

2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: statistical approaches to establishing bioequivalence. January 2001. https://www.fda.gov/media/70958/download. [Accessed 26 Nov 2019].

3. Concordet D, Gandia P, Montastruc J-L, Bousquet-Mélou A, Lees P, Ferran AA, et al. Authors’ reply to Coste et al.: Levothyrox® new and old formulations: are they switchable for millions of patients? Clin Pharmacokinet. 2019;58(7):967–8. https://doi.org/10.1007/s40262-019-00747-3.

4. 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. https://doi.org/10.1007/s40262-019-00812-x.

5. Anonymous. Draft guidance on levothyroxine sodium. Food and Drug Administration; 2018: :p. 2. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428208.pdf. Accessed 4 Oct 2019.

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