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?”-Reference-Cited by-同舟云学术

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?”

Published:2019-12-05 Issue:2 Volume:59 Page:277-279
ISSN:0312-5963
Container-title:Clinical Pharmacokinetics
language:en
Short-container-title:Clin Pharmacokinet

Author:

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

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40262-019-00851-4.pdf

Reference16 articles.

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. https://doi.org/10.1007/s40262-019-00849-y.

2. 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.

3. 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;58:827–33. https://doi.org/10.1007/s40262-019-00747-3.

4. Morais JAG, Lobato Mdo R. The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol. 2010;106(3):221–5.

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 Draft guidance on levothyroxine sodium.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.