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
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 , 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 .
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- 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