Bioanalytical Methods Validation for Human Studies - Pharmanet
Bioanalytical Methods Validation for Human Studies - Pharmanet
Bioanalytical Methods Validation for Human Studies - Pharmanet
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Draft — Not <strong>for</strong> Implementation<br />
Table of Contents<br />
I. INTRODUCTION ....................................................1<br />
II. BACKGROUND .....................................................1<br />
III. REFERENCE STANDARD ............................................2<br />
IV. PRE-STUDY VALIDATION ...........................................3<br />
A. Specificity .....................................................3<br />
B. Calibration Curve ..............................................4<br />
C. Precision, Accuracy, and Recovery .................................5<br />
D. Quality Control Samples .........................................6<br />
E. Stability .......................................................7<br />
F. Acceptance Criteria .............................................9<br />
V. IN-STUDY VALIDATION .............................................9<br />
VI. DOCUMENTATION .................................................10<br />
REFERENCES ...........................................................13<br />
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