Recommendations on incurred sample stability (ISS) by GCC.
The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.
Quintiles Bioanalytical & ADME Labs, Ithaca, NY, USA.
Steve
S
Lowes
Richard
R
LeLacheur
Ronald
R
Shoup
Fabio
F
Garofolo
Isabelle
I
Dumont
Suzanne
S
Martinez
Jennifer
J
Zimmer
Maria Cruz
MC
Caturla
Philippe
P
Couerbe
Kayode
K
Awaiye
Saadya
S
Fatmi
Raymond
R
Farmen
Curtis
C
Sheldon
Joseph
J
Bower
Michele
M
Fiscella
Douglas
D
Fast
Stephanie
S
Cape
Jim
J
Hulse
John
J
Kamerud
Tee
T
Zhang
Stephanie
S
Pasas-Farmer
Wei
W
Garofolo
Marc
M
Moussallie
Mario
M
Rocci
John
J
Allinson
Dominique
D
Gouty
Mike
M
Buonarati
Nadine
N
Boudreau
Brigitte
B
Pellerin
Jenny
J
Lin
Allan
A
Xu
Roger
R
Hayes
Mohammed
M
Bouhajib
Mary
M
Stipancic
Robert
R
Nicholson
Corey
C
Nehls
Mark
M
Warren
Shane
S
Karnik
Richard
R
Houghton
Craig
C
Stovold
Scott
S
Reuschel
Laura
L
Cojocaru
John
J
Marcelletti
Xinping
X
Fang
Ian
I
Smith
Andrea
A
Watson
D019963:Clinical Chemistry Tests; D003625:Data Collection; D015203:Reproducibility of Results