Skip to main content
SpringerLink
Log in

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

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

The Original Article was published on 04 April 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

Fig. 1

Data availability

Data are available as Electronic Supplementary Material from reference [1].

References

  1. Concordet D, Gandia P, Montastruc JL, 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.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Concordet D, Gandia P, Montastruc JL, 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. 2020;59(1):1–5. https://doi.org/10.1007/s40262-019-00812-x.

    Article  PubMed  Google Scholar 

  3. 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. 2020;59:265–7. https://doi.org/10.1007/s40262-019-00847-0.

    Article  PubMed  Google Scholar 

  4. 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. 2020;59:273–5. https://doi.org/10.1007/s40262-019-00849-y.

    Article  PubMed  Google Scholar 

  5. 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. https://doi.org/10.1080/03007995.2016.1246434.

    Article  CAS  PubMed  Google Scholar 

  6. L'ansm. L'ansm publie les résultats des enquêtes nationales de pharmacovigilance sur les spécialités à base de lévothyroxine—communiqué. 2018. https://ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/L-ANSM-publie-les-resultats-des-enquetes-nationales-de-pharmacovigilance-sur-les-specialites-a-base-de-levothyroxine-Communique. Accessed 25 Mar 2020.

  7. Chow SC. Bioavailability and bioequivalence in drug development. Wiley Interdiscip Rev Comput Stat. 2014;6:304–12. https://doi.org/10.1002/wics.1310.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Krehan A, Dittmar M, Hoppen A, Lichtwald K, Kahaly GJ. Randomized, double-blind crossover study of bioavailability of levothyroxine. Med Klin (Munich). 2002;97:522–7. https://doi.org/10.1007/s00063-002-1190-4.

    Article  Google Scholar 

  9. Hoermann R, Midgley JEM, Larisch R, Dietrich JW. Individualised requirements for optimum treatment of hypothyroidism: complex needs, limited options. Drugs Context. 2019;8:212597. https://doi.org/10.7573/dic.212597.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Andersen S, Pedersen KM, Bruun NH, Laurberg P. Narrow individual variations in serum T4 and T3 in normal subjects: a clue to the understanding of subclinical thyroid disease. J Clin Endocrinol Metab. 2002;87:1068–72. https://doi.org/10.1210/jcem.87.3.8165.

    Article  CAS  PubMed  Google Scholar 

  11. Hoermann R, Midgley JEM, Larisch R, Dietrich JW. Functional and symptomatic individuality in the response to levothyroxine treatment. Front Endocrinol (Lausanne). 2019;26(10):664. https://doi.org/10.3389/fendo.2019.00664.

    Article  Google Scholar 

  12. Molenaar PCM, Campbell CG. The new person-specific paradigm in psychology. Curr Dir Psychol Sci. 2009;18:112–7. https://doi.org/10.1111/j.1467-8721.2009.01619.x.

    Article  Google Scholar 

Download references

Funding

This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.

Author information

Authors and Affiliations

  1. Department for Nuclear Medicine, Klinikum Lüdenscheid, Paulmannshöher Str 14, 58515, Lüdenscheid, Germany

    Rudolf Hoermann & Rolf Larisch

  2. North Lakes Clinical, Ilkley, UK

    John E. M. Midgley

  3. Medical Department I, Endocrinology and Diabetology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany

    Johannes W. Dietrich

  4. Ruhr Center for Rare Diseases (CeSER), Ruhr University of Bochum and Witten/Herdecke University, Bochum, Germany

    Johannes W. Dietrich

Authors
  1. Rudolf Hoermann
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. John E. M. Midgley
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rolf Larisch
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Johannes W. Dietrich
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

RH drafted the manuscript and JEM, RL and JWD contributed additional ideas and text to the final jointly approved article.

Corresponding author

Correspondence to Rudolf Hoermann.

Ethics declarations

Conflict of interest

Johannes W. Dietrich is the co-owner of the intellectual property rights for the patent “System and Method for Deriving Parameters for Homeostatic Feedback Control of an Individual” (Singapore Institute for Clinical Sciences, Biomedical Sciences Institutes, Application Number 201208940-5, WIPO number WO/2014/088516). Rudolf Hoermann, John E.M. Midgley and Rolf Larisch have no conflicts of interest that could be perceived as prejudicing the impartiality of the research reported.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hoermann, R., Midgley, J.E.M., Larisch, R. et al. Comment on “Levothyrox® New and Old Formulations: Are They Switchable for Millions of Patients?”. Clin Pharmacokinet 59, 655–657 (2020). https://doi.org/10.1007/s40262-020-00887-x

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40262-020-00887-x

Search

Navigation