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Comment
. 2020 Feb;59(2):269-271.
doi: 10.1007/s40262-019-00848-z.

Authors' Reply to Krebs-Brown et al. Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"

D Concordet  1 , P Gandia  1 , J L Montastruc  2 , A Bousquet-Mélou  1 , P Lees  3 , A A Ferran  1 , P L Toutain  4   5
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Comment

Authors' Reply to Krebs-Brown et al. Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"

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

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Conflict of interest statement

D Concordet, P. Gandia, J.L. Montastruc, A. Bousquet-Mélou, P. Lees, A.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. Krebs-Brown A, Munafo A, Gaikwad S, Urgatz B, Castello-Bridoux C. 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/s40262-019-00847-0. - DOI - PMC - PubMed
    1. Anonymous. Status of EMEA scientific guidelines and European pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products. 2008. https://www.ema.europa.eu/en/documents/scientific-guideline/status-emea-.... Accessed 21 Nov 2019.
    1. Anonymous. Concept paper on the development of product-specific guidance on demonstration of bioequivalence. 2013. https://www.ema.europa.eu/en/documents/scientific-guideline/concept-pape.... Accessed 21 Nov 2019.
    1. Anonymous. An open-label, single-dose, randomized, two-period, two-sequence crossover, single-center trial to assess bioequivalence of 600 µg Ievothyroxine new formulation versus old formulation administered orally as 3 white tablets of 200 µg in healthy volunteers. 2014. https://ansm.sante.fr/var/ansm_site/storage/original/application/3606e51.... Accessed 21 Nov 2019.
    1. Anonymous. Draft guidance on levothyroxine sodium (p. 2). 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat.... Accessed 4 Oct 2019.

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