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. 1. Safety Risk Management, Licensing & Early Development, F. Hoffmann-La Roche AG, Basel, Switzerland. maria.longauer_banholzer@roche.com. 2. Safety Risk Management, Licensing & Early Development, F. Hoffmann-La Roche AG, Basel, Switzerland. 3. Pharma Research & Early Development, Roche Innovation Center Basel, Pharmaceutical Sciences, F. Hoffmann-La Roche AG, Basel, Switzerland. 4. Safety Risk Management, Licensing & Early Development, F. Hoffmann-La Roche Ltd, New York, NY, USA. 5. Pharma Research & Early Development, Roche Innovation Center Basel, Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland. 6. Non-Clinical Safety Department, Genentech Inc, South San Francisco, CA, USA. 7. , Zurich, Switzerland.
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].
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