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Comment
. 2019 Jul;58(7):967-968.
doi: 10.1007/s40262-019-00780-2.

Authors' Reply to Coste et al.: "Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?"

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
Affiliations
Comment

Authors' Reply to Coste et al.: "Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?"

Didier Concordet et al. Clin Pharmacokinet. 2019 Jul.
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 content of this reply.

Comment on

References

    1. Coste J, Bertagna X, Zureik M. Comment on: “Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?”. Clin Pharmacokinet. 2019 doi: 10.1007/s40262-019-00779-9. - DOI - PubMed
    1. Anonymous. “Guideline on the investigation of bioequivalence” (EMA, London, 2010). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin.... Accessed 28 Apr 2019.
    1. Anonymous. Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. Draft guidance. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 2013 Biopharmaceutics. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat.... Accessed 28 Apr 2019.
    1. Anonymous. Levothyrox; preliminary assessment report. Pharmacokinetic comment on a generic application. Rapport interne ANSM sur les études de bioéquivalence (15/09/2017). ANSM. https://www.ansm.sante.fr/content/download/110115/1395469/version/1/file.... Accessed 28 Apr 2019.
    1. Blakesley VA. Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. AAPS J. 2005;7:E42–E46. doi: 10.1208/aapsj070105. - DOI - PMC - PubMed

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