Technical / White Paper

Starting Dose Selection in First-in-Human Trials

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Format: PDF file | Document type: Technical / White Paper

Starting Dose Selection in First-in-Human Trials

Following the life-threatening adverse event that occurred after the FIH adminis­tration of a CD28 super-agonist antibody, early testing in humans was revisited by a UK scientific expert. Based on the resulting "Duff Report", the Euro­pean Medicines Agency (EMEA) drafted new guidance underlining the need to better miti­gate the risk when first-in-human dosing is concerned. This paper aims at presenting diverse strategies supporting the choice of the starting dose that were seen in recent FIH trials conducted at the SGS Clinical Pharmacology Units.

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