Open Access

Erratum to: Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update

  • Maria Longauer Banholzer1Email author,
  • Christoph Wandel1,
  • Paul Barrow3,
  • Marie Mannino2,
  • Georg Schmitt3,
  • Melanie Guérard3,
  • Lutz Müller3,
  • Gerard Greig4,
  • Kenjie Amemiya5,
  • Richard Peck4,
  • Thomas Singer3 and
  • Lucette Doessegger6
Clinical and Translational Medicine20165:30

https://doi.org/10.1186/s40169-016-0115-4

Received: 29 July 2016

Accepted: 2 August 2016

Published: 12 August 2016

The original article was published in Clinical and Translational Medicine 2016 5:23

Erratum to: Clin Trans Med (2016) 5:23 DOI 10.1186/s40169-016-0103-8

Following publication of the original article in Clinical and Translational Medicine [1], it was brought to our attention that there is an error in the section “Safety margin considerations”.

The second sentence of the first paragraph of the section “Safety margin considerations” currently reads: “For first-in-human studies applying a range of escalating doses, the FDA suggests a default safety factor of ten between the exposure for the starting dose and that of the Human Equivalent Dose, which should be individualized [27]”.

This text should read: For first-in-human studies applying a range of escalating doses, the FDA suggests a default safety factor of ten between the NOAEL in GLP toxicology studies in animals and the starting dose expressed as Human Equivalent Dose of the first-in-human study. The safety margin should be individualized by compound [27].

Notes

Declarations

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors’ Affiliations

(1)
Safety Risk Management, Licensing & Early Development, F. Hoffmann-La Roche AG
(2)
Safety Risk Management, Licensing & Early Development, F. Hoffmann-La Roche Ltd
(3)
Pharma Research & Early Development, Roche Innovation Center Basel, Pharmaceutical Sciences, F. Hoffmann-La Roche AG
(4)
Pharma Research & Early Development, Roche Innovation Center Basel, Clinical Pharmacology, F. Hoffmann-La Roche AG
(5)
Non-Clinical Safety Department, Genentech Inc
(6)

Reference

  1. Banholzer ML, Wandel C, Barrow P, Mannino M, Schmitt G, Guérard M, Müller L, Greig G, Amemiya K, Peck R, Singer T, Doessegger L (2016) Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update. Clin Transl Med 5:23View ArticlePubMedPubMed CentralGoogle Scholar

Copyright

© The Author(s) 2016