Bioanalytical Methods Validation for Human Studies - Pharmanet

Draft — Not for Implementation
Table of Contents
I. INTRODUCTION ....................................................1
II. BACKGROUND .....................................................1
III. REFERENCE STANDARD ............................................2
IV. PRE-STUDY VALIDATION ...........................................3
A. Specificity .....................................................3
B. Calibration Curve ..............................................4
C. Precision, Accuracy, and Recovery .................................5
D. Quality Control Samples .........................................6
E. Stability .......................................................7
F. Acceptance Criteria .............................................9
V. IN-STUDY VALIDATION .............................................9
VI. DOCUMENTATION .................................................10
REFERENCES ...........................................................13
j:\!guidance\2578dft.wpd
12/14/98 i