TABLE I

Simulated Potency Performance Data for 40 Batches

Batch No.Percent of Samples Meeting SpecBatch No.Percent of Samples Meeting SpecBatch No.Percent of Samples Meeting SpecBatch No.Percent of Samples Meeting Spec
10.985110.947210.96031.00.951
20.828120.920220.91432.00.973
30.995130.950230.99833.00.922
40.896140.972240.90834.00.924
50.998150.943250.95135.00.946
60.952160.939260.96336.00.975
70.889170.941270.97837.00.978
80.973180.981280.94638.00.912
90.979190.975290.98139.00.871
100.957200.848300.98140.00.872