Skip to main content
SpringerLink
Log in

Comment on: “Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?”

  • Letter to the Editor
  • Published:
Clinical Pharmacokinetics Aims and scope Submit manuscript

A Letter to the Editor to this article was published on 05 December 2019

The Original Article was published on 21 August 2019

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Notes

  1. The reference [13] quoted by Concordet et al. does not contain such data.

References

  1. Concordet D, Gandia P, Montastruc J-L, Bousquet-Melou A, Lees P, Ferran A, Toutain P-L. Why were more than 200 subjects required to demonstrate the bioequivalence of a new formulation of Levothyroxine with an old one? Clin Pharmacokinet. Epub 21 Aug 2019. https://doi.org/10.1007/s40262-019-00812-x.

  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.

    Article  CAS  Google Scholar 

  3. Nicolas P. Comment on: “Levothyrox® new and old formulations: are they switchable for millions of patients? Clin Pharmacokinet. 2019;58:959.

    Article  Google Scholar 

  4. Yu LX. Quality and bioequivalence standards for narrow therapeutic index drugs. GPhA 2011 Fall Technical Workshop. Available at: https://www.fda.gov/media/82940/download. Accessed 22 Sep 2019.

  5. Munk A. Connections between average and individual bioequivalence. Stat Med. 2000;19:2843–54.

    Article  CAS  Google Scholar 

  6. Chow S-C., Endrenyi L, Chi E, Yang L-L., Tothfalusi L. Statistical issues in bioavailability/bioequivalence studies. J Bioequiv Availab. 2011;S1. https://doi.org/10.4172/jbb.s1-007.

  7. Yu Y, Teerenstra S, Neef C, Burger D, Maliepaard M. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials. Br J Clin Pharmacol. 2015;81(4):667–78.

    Article  Google Scholar 

  8. Di Girolamo G, Keller GA, de los Santos AR, Schere D, Gonzalez CD. Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study. Clin Ther. 2008;30(11):2015–2023.

  9. Levothyroxine (as sodium). EU-procedure number: NL/H/2567/001-004/DC, 2014. Available at: https://www.geneesmiddeleninformatiebank.nl/Pars/h111900.pdf. Accessed 22 Sep 2019.

  10. Australian public assessment report for thyroxine sodium, 2014. Available at: https://www.tga.gov.au/sites/default/files/auspar-thyroxine-sodium-140612.pdf. Accessed 22 Sep 2019.

  11. Levothyroxine sodium soft capsules. Procedure number DE/H/2580/01-12/DC, 2011. Available at: http://mri.cts-mrp.eu/download/DE_H_2580_011_PAR.pdf. Accessed 22 Sep 2019.

  12. Levothyroxine sodium. Procedure NL/H/2700/001-011/DC, 2015. Available at: https://db.cbg-meb.nl/Pars/h112415.pdf. Accessed 22 Sep 2019.

  13. Levothyroxine sodium. UK Licence no. PL00289/1971-73, 2016. http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con738143.pdf. Accessed 22 Sep 2019.

  14. Tanguay M, Girard J, Scarci C, Mautone G, Larouche R. Pharmacokinetic and comparative bioavailability of a levothyroxine sodium oral solution and soft capsule. Clin Pharmacol Drug Dev. 2019;8(4):521–8.

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Assistance Publique des Hôpitaux de Paris (APHP), Bobigny, Seine Saint-Denis, France

    Patrick Nicolas

Authors
  1. Patrick Nicolas
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Patrick Nicolas.

Ethics declarations

Funding

No sources of funding were used in the preparation of this manuscript.

Conflict of interest

Patrick Nicolas declares no potential conflicts of interest that might be relevant to the contents of this letter.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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 59, 273–275 (2020). https://doi.org/10.1007/s40262-019-00849-y

Download citation

  • Published:

  • Issue Date:

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

Search

Navigation