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01-10-2019 | Levothyroxine | Letter to the Editor

Comment on: “Levothyrox^® New and Old Formulations: Are they Switchable for Millions of Patients?”

Authors: Philippe Lechat, Jacques Ropers, Jérome Barré, Stephane Mouly

Published in: Clinical Pharmacokinetics | Issue 10/2019

Excerpt

We read with interest the article by Concordet et al. on the analysis of the bioequivalence study between old and new formulations of Levothyrox^®, which was recently published in Clinical Pharmacokinetics [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(7):827–33. https://doi.org/10.1007/s40262-019-00747-3(Epub 4 Apr 2019).CrossRefPubMedPubMedCentral

FDA Guidance document “Statistical Approaches to Establishing Bioequivalence”. 2001. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence. Accessed 20 June 2019.

ANSM Levothyrox public report. https://www.ansm.sante.fr/content/download/110115/1395469/version/1/file/Rapport+d%C3%A9valuation+bioequivalence+_+Levothyrox.pdf. Accessed 20 June 2019.

ANSM: Contrôle de la nouvelle formule de Lévothyrox commercialisée à partir de mars 2017: note de synthèse 17-A-12th September 2017. file:///C:/Users/502264/Downloads/Rapport%20danalyse%20Agence%20(CTROL)%20_%20Levothyrox.pdf.

Pharmacovigilance report: third report 6/7/2018 Comité technique de pharmacovigilance du 06/07/2018. http://www.ansm.sante.fr. Accessed 20 June 2019.

Title: Comment on: “Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?”
Authors: Philippe Lechat
Jacques Ropers
Jérome Barré
Stephane Mouly
Publication date: 01-10-2019
Publisher: Springer International Publishing
Keyword: Levothyroxine
Published in: Clinical Pharmacokinetics / Issue 10/2019
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI: https://doi.org/10.1007/s40262-019-00814-9

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