Dosage Units Using Small and Large Sample Sizes: Uniformity

Authored by: Meiyu Shen , Yi Tsong

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000068

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Abstract

The purpose of uniformity of dosage unit test is to determine the degree of uniformity in the amount of drug substance among dosage units in a batch. Content uniformity test is based on the assay of the individual content of drug substance(s) in a number of dosage units. Content uniformity test is required by the regulatory authorities such as US Food and Drug Administration to confirm that the unit dose of a drug product is consistent with the label claim. Although USP <905> is not intended for batch releases as it is clearly declared in the general notices and requirements of the USP pharmacopeia, many pharmaceutical companies still propose to implement USP <905> as their batch release specification. We present the details of USP <905> and propose a two one-sided parametric tolerance interval for small samples. We also present the details of parametric and nonparametric methods by European Pharmacopoeia 8.1 and propose a parametric tolerance interval method for large samples. Furthermore, we discuss the performances of these acceptance sampling plans.

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