Some Statistical Aspects of Pharmaceutical Content Uniformity

Abstract

Drug content uniformity among individual dosage units of pharmaceutical products has received increasing attention over recent years. Sampling plans and specifications set forth in the official compendia to which the industry is bound are attribute plans based upon variables measurements. These plans do not efficiently utilize all of the information available to the analyst nor do they include provisions for quantifying the decisions in a probabilistic sense. The authors consider procedures for correcting these shortcomings through combining both unit weight and quantitative assay data into alternative statements of information content which could be useful in evaluating pharmaceutical quality. Areas requiring further theoretical development are outlined.

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