Definition of multivariate acceptance limits (guard-bands) applied to pharmaceutical equivalence assessment.
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DOI: 10.2139/ssrn.4135102
Abstract: The quality assessment of medicines involves multiple compliance parameters, such as identity, dosage, purity, potency, content uniformity, disintegration time, dissolution rate, among others. The measurement uncertainty associated with a measured value can affect the conformity… read more here.
Keywords: acceptance; guard bands; assessment; pharmaceutical equivalence ... See more keywords