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].
Reference
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 5:23
Author information
Authors and Affiliations
Corresponding author
Additional information
The online version of the original article can be found under doi:10.1186/s40169-016-0103-8.
Rights and permissions
Open Access This 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.
About this article
Cite this article
Banholzer, M.L., Wandel, C., Barrow, P. et al. Erratum to: Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update. Clin Trans Med 5, 30 (2016). https://doi.org/10.1186/s40169-016-0115-4
Received:
Accepted:
Published:
DOI: https://doi.org/10.1186/s40169-016-0115-4