pt provider roundtable
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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
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