Towards consensus practices to qualify safety biomarkers for use in early drug development.
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.
Sistare
Frank D
FD
Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA. frank_sistare@merck.com
Dieterle
Frank
F
Troth
Sean
S
Holder
Daniel J
DJ
Gerhold
David
D
Andrews-Cleavenger
Dina
D
Baer
William
W
Betton
Graham
G
Bounous
Denise
D
Carl
Kevin
K
Collins
Nathaniel
N
Goering
Peter
P
Goodsaid
Federico
F
Gu
Yi-Zhong
YZ
Guilpin
Valerie
V
Harpur
Ernie
E
Hassan
Alita
A
Jacobson-Kram
David
D
Kasper
Peter
P
Laurie
David
D
Lima
Beatriz Silva
BS
Maciulaitis
Romaldas
R
Mattes
William
W
Maurer
Gérard
G
Obert
Leslie Ann
LA
Ozer
Josef
J
Papaluca-Amati
Marisa
M
Phillips
Jonathan A
JA
Pinches
Mark
M
Schipper
Matthew J
MJ
Thompson
Karol L
KL
Vamvakas
Spiros
S
Vidal
Jean-Marc
JM
Vonderscher
Jacky
J
Walker
Elizabeth
E
Webb
Craig
C
Yu
Yan
Y
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
D015415:Biomarkers; D004364:Pharmaceutical Preparations
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