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.

Keywords

Computer scienceQuality (philosophy)Set (abstract data type)Content (measure theory)Pharmaceutical industrySampling (signal processing)Probabilistic logicOperations researchData miningRisk analysis (engineering)MathematicsBusinessArtificial intelligenceBiotechnology

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Publication Info

Year
1971
Type
article
Volume
3
Issue
4
Pages
170-178
Citations
8
Access
Closed

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Social media, news, blog, policy document mentions

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8
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1
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7
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Cite This

C. B. Sampson, H. Latham Breunig (1971). Some Statistical Aspects of Pharmaceutical Content Uniformity. Journal of Quality Technology , 3 (4) , 170-178. https://doi.org/10.1080/00224065.1971.11980490

Identifiers

DOI
10.1080/00224065.1971.11980490

Data Quality

Data completeness: 77%