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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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Notes on contributors
Charles B. Sampson
Dr. Sampson and Dr. Breunig are Senior Statisticians in the Statistical Research Department of Eli Lilly and Company and are concerned with the application of statistical methodology to pharmaceutical research, development, control and manufacturing. Dr. Breunig is a Fellow of ASQC and past Chairman of its Chemical Division.