Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.
Dieterle
Frank
F
Novartis Pharma AG, Basel, Switzerland. frank.dieterle@novartis.com
Sistare
Frank
F
Goodsaid
Federico
F
Papaluca
Marisa
M
Ozer
Josef S
JS
Webb
Craig P
CP
Baer
William
W
Senagore
Anthony
A
Schipper
Matthew J
MJ
Vonderscher
Jacky
J
Sultana
Stefan
S
Gerhold
David L
DL
Phillips
Jonathan A
JA
Maurer
Gérard
G
Carl
Kevin
K
Laurie
David
D
Harpur
Ernie
E
Sonee
Manisha
M
Ennulat
Daniela
D
Holder
Dan
D
Andrews-Cleavenger
Dina
D
Gu
Yi-Zhong
YZ
Thompson
Karol L
KL
Goering
Peter L
PL
Vidal
Jean-Marc
JM
Abadie
Eric
E
Maciulaitis
Romaldas
R
Jacobson-Kram
David
D
Defelice
Albert F
AF
Hausner
Elizabeth A
EA
Blank
Melanie
M
Thompson
Aliza
A
Harlow
Patricia
P
Throckmorton
Douglas
D
Xiao
Shen
S
Xu
Nancy
N
Taylor
William
W
Vamvakas
Spiros
S
Flamion
Bruno
B
Lima
Beatriz Silva
BS
Kasper
Peter
P
Pasanen
Markku
M
Prasad
Krishna
K
Troth
Sean
S
Bounous
Denise
D
Robinson-Gravatt
Denise
D
Betton
Graham
G
Davis
Myrtle A
MA
Akunda
Jackie
J
McDuffie
James Eric
JE
Suter
Laura
L
Obert
Leslie
L
Guffroy
Magalie
M
Pinches
Mark
M
Jayadev
Supriya
S
Blomme
Eric A
EA
Beushausen
Sven A
SA
Barlow
Valérie G
VG
Collins
Nathaniel
N
Waring
Jeff
J
Honor
David
D
Snook
Sandra
S
Lee
Jinhe
J
Rossi
Phil
P
Walker
Elizabeth
E
Mattes
William
W
D000818:Animals; D054316:Biomarkers, Pharmacological; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000293:injuries; D004364:Pharmaceutical Preparations / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations
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