- Open Access
Erratum to: Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update
© The Author(s) 2016
- 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
Following publication of the original article in Clinical and Translational Medicine , 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 ”.
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 .
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.
- 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