Abstract
A simulation study was performed to investigate the statistical power of the revised US Pharmacopeial Convention, Inc. and Bergum’s revised test acceptance limits for 95% confidence. In this simulation exercise, relatively small artificial lots of dosage units (20,000 U) were created to represent various probability distributions with increasing levels of defects. A simulation tool was developed to extract valid samples from each lot and perform the compendial test repeatedly for a minimum of 11,000 trials. This paper describes the results of these simulation trials.
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