Statistically sound proposals for the content uniformity test of solid drug products

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  Two major aspects of drug quality assessment are: assay and content uniformity tests.Assay value reflects the mean active content in a production batch.The content uniformity test shows the distribution of the active content.The European Pharmacopoeia has introduced a significant change in the calculation of the content uniformity values and in their acceptance criteria in 2005 and the United States Pharmacopeia adopted these regulations in January, 2007.
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