Fit-for-purpose method development and validation for successful biomarker measurement.
Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are employed in an attempt to speed new drugs to market. Still, widespread adoption of biomarkers is impeded by limited experience interpreting biomarker data and an unclear regulatory climate. Key differences preclude the direct application of existing validation paradigms for drug analysis to biomarker research. Following the AAPS 2003 Biomarker Workshop (J. W. Lee, R. S. Weiner, J. M. Sailstad, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report. Pharm Res 22:499-511, 2005), these and other critical issues were addressed. A practical, iterative, "fit-for-purpose" approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use. Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development.
Lee
Jean W
JW
Formerly MDS Pharma Services, Lincoln, Nebraska, USA. jwlee@amgen.com
Devanarayan
Viswanath
V
Barrett
Yu Chen
YC
Weiner
Russell
R
Allinson
John
J
Fountain
Scott
S
Keller
Stephen
S
Weinryb
Ira
I
Green
Marie
M
Duan
Larry
L
Rogers
James A
JA
Millham
Robert
R
O'Brien
Peter J
PJ
Sailstad
Jeff
J
Khan
Masood
M
Ray
Chad
C
Wagner
John A
JA
D015415:Biomarkers / Q000032:analysis* / Q000737:chemistry; D002138:Calibration; D003627:Data Interpretation, Statistical; D015195:Drug Design; D015233:Models, Statistical; D011786:Quality Control; D015203:Reproducibility of Results; D009626:Terminology as Topic
D015415:Biomarkers