Literature DB >> 27520795

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

Maria Longauer Banholzer1, Christoph Wandel2, Paul Barrow3, Marie Mannino4, Georg Schmitt3, Melanie Guérard3, Lutz Müller3, Gerard Greig5, Kenjie Amemiya6, Richard Peck5, Thomas Singer3, Lucette Doessegger7.   

Abstract

Entities:  

Year:  2016        PMID: 27520795      PMCID: PMC4987740          DOI: 10.1186/s40169-016-0115-4

Source DB:  PubMed          Journal:  Clin Transl Med        ISSN: 2001-1326


× No keyword cloud information.

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].
  1 in total

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

Authors:  Maria Longauer Banholzer; Christoph Wandel; Paul Barrow; Marie Mannino; Georg Schmitt; Melanie Guérard; Lutz Müller; Gerard Greig; Kenjie Amemiya; Richard Peck; Thomas Singer; Lucette Doessegger
Journal:  Clin Transl Med       Date:  2016-07-25
  1 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.