PT Provider Roundtable

Chuck Wibby

College of New Jersey

February 26, 2004

NELAC Acceptance Limits

Fixed Limits+15%Centered on assigned value (100% concentration)

Regression equationsCentered on expected mean recoveryRegression equation SDs

CombinationsCentered on study meanRegression equation SDs

Regression equations

Regression equations

Y = mx + ba, b, c, d????Predicted mean = (Assigned Value * a) + bPredicted SD = (Assigned Value * c) + dWS Acceptance Limits = Pred mean + 2 *

Pred SDWP Acceptance Limits = Pred mean + 3 *

Pred SD

Manufacturing

Verification

Homogeneity

Post Study

Stability

Post Study

Thank You!

Chuck Wibby303-940-0033, ext 201

cwibby@wibby.com

Keith Ward303-940-0033, ext 202

kward@wibby.com

Ty Garber303-940-0033, ext 213

tgarber@wibby.com