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KMID : 0383919750120000105
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Report of National Institute of Health
1975 Volume.12 No. 0 p.105 ~ p.108
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A Study on the content uniformity
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백덕우/Paik, D.W.
강신복/김길수/김운장/Kang, S.B./Kim, K.S./Kim, W.J.
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Abstract
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The operating characteristic of the official content uniformity plans is developed interms of proportion defective in a lot. This proportion defective is represented as a function of the means and variances, respectively, of the drug substance weight and the tablet weight. It is then shown that the probability of acceptance of a lot can be derived for each process from knowledge of only; (a) the coefficient of variation, and (b) the proportional process bias. That is the proportion defective in a lot is considered in terms of departures from theoretical drug substance weight and target tablet weight and their coefficients of variation which can arise in normal manufacturing operations. A completely worked example of these calculations outlines the procedure. The tables show the probablity of acceptance arising through the interplay of several selected values of the coefficients of variation and of the proportional process bias.
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KEYWORD
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