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PT Provider Roundtable Chuck Wibby College of New Jersey February 26, 2004

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NELAC Acceptance Limits Fixed Limits +15% Centered on assigned value (100% concentration) Regression equations Centered on expected mean recovery Regression equation SDs Combinations Centered on study mean Regression equation SDs

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Regression equations

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Y = mx + b a, b, c, d???? Predicted mean = (Assigned Value * a) + b Predicted SD = (Assigned Value * c) + d WS Acceptance Limits = Pred mean + 2 * Pred SD WP Acceptance Limits = Pred mean + 3 * Pred SD

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Manufacturing

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Verification

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Homogeneity

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Post Study

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Stability

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Post Study

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Thank You! Chuck Wibby 303-940-0033, ext 201 cwibby@wibby.com Keith Ward 303-940-0033, ext 202 kward@wibby.com Ty Garber 303-940-0033, ext 213 tgarber@wibby.com

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