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

Author:

Nicolas PatrickORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference5 articles.

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. Epub 2019 Apr 4. https://doi.org/10.1007/s40262-019-00747-3.

2. Gottwald-Hostalek U, Uhl W, Wolna P, Kahaly GJ. New levothyroxine formulation meeting 95-105% specification over the whole shelf-life: results from two pharmacokinetic trials. Curr Med Res Opin. 2017;33:169–74.

3. Guidance for Industry. Draft guidance on levothyroxine sodium. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_draft_Oral tab_RLD 021116 021210 021301 021342 321402_RC12-14.pdf. Accessed 24 May 2019.

4. Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, et al. A bioequivalence approach for generic narrow therapeutic index drugs: evaluation of the reference-scaled approach and variability comparison criterion. AAPS J. 2015;17(4):891–901.

5. Peeters RP, Visser TJ. Metabolism of thyroid hormone [Updated 2017 Jan 1]. In: Feingold KR, Anawalt B, Boyce A, et al., editors. Endotext. South Dartmouth: MDText.com, Inc.; 2000. https://www.ncbi.nlm.nih.gov/books/NBK285545/. Accessed 24 May 2019.

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