title: Towards consensus practices to qualify safety biomarkers for use in early drug development.
abstract: Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an approach enables stakeholders from industry and regulatory bodies to objectively evaluate whether superior standards of performance have been met and whether specific claims of fit-for-purpose use are supported. It is therefore important during the biomarker evaluation process that stakeholders seek agreement on which critical experiments are needed to test that a biomarker meets specific performance claims, how new biomarker and traditional comparators will be measured and how the resulting data will be merged, analyzed and interpreted.
authors.affiliation: Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA. frank_sistare@merck.com
authors.forename: Frank D
authors.initials: FD
authors.lastname: Sistare
authors.forename: Frank
authors.initials: F
authors.lastname: Dieterle
authors.forename: Sean
authors.initials: S
authors.lastname: Troth
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Holder
authors.forename: David
authors.initials: D
authors.lastname: Gerhold
authors.forename: Dina
authors.initials: D
authors.lastname: Andrews-Cleavenger
authors.forename: William
authors.initials: W
authors.lastname: Baer
authors.forename: Graham
authors.initials: G
authors.lastname: Betton
authors.forename: Denise
authors.initials: D
authors.lastname: Bounous
authors.forename: Kevin
authors.initials: K
authors.lastname: Carl
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Collins
authors.forename: Peter
authors.initials: P
authors.lastname: Goering
authors.forename: Federico
authors.initials: F
authors.lastname: Goodsaid
authors.forename: Yi-Zhong
authors.initials: YZ
authors.lastname: Gu
authors.forename: Valerie
authors.initials: V
authors.lastname: Guilpin
authors.forename: Ernie
authors.initials: E
authors.lastname: Harpur
authors.forename: Alita
authors.initials: A
authors.lastname: Hassan
authors.forename: David
authors.initials: D
authors.lastname: Jacobson-Kram
authors.forename: Peter
authors.initials: P
authors.lastname: Kasper
authors.forename: David
authors.initials: D
authors.lastname: Laurie
authors.forename: Beatriz Silva
authors.initials: BS
authors.lastname: Lima
authors.forename: Romaldas
authors.initials: R
authors.lastname: Maciulaitis
authors.forename: William
authors.initials: W
authors.lastname: Mattes
authors.forename: Gérard
authors.initials: G
authors.lastname: Maurer
authors.forename: Leslie Ann
authors.initials: LA
authors.lastname: Obert
authors.forename: Josef
authors.initials: J
authors.lastname: Ozer
authors.forename: Marisa
authors.initials: M
authors.lastname: Papaluca-Amati
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Phillips
authors.forename: Mark
authors.initials: M
authors.lastname: Pinches
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Schipper
authors.forename: Karol L
authors.initials: KL
authors.lastname: Thompson
authors.forename: Spiros
authors.initials: S
authors.lastname: Vamvakas
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Vidal
authors.forename: Jacky
authors.initials: J
authors.lastname: Vonderscher
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Walker
authors.forename: Craig
authors.initials: C
authors.lastname: Webb
authors.forename: Yan
authors.initials: Y
authors.lastname: Yu
mesh_terms: D000818:Animals; D015415:Biomarkers; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations
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