Evaluation of U. S. Pharmacopeia Sampling Plans for Dissolution
作者:
PheattCharles B.,
期刊:
Journal of Quality Technology
(Taylor Available online 1980)
卷期:
Volume 12,
issue 3
页码: 158-164
ISSN:0022-4065
年代: 1980
DOI:10.1080/00224065.1980.11980955
出版商: Taylor&Francis
关键词: Dissolution Testing;USP Sampling Requirements;Monte Carlo Simulation;Operating Characteristic Curve
数据来源: Taylor
摘要:
The United States Pharmacopeiapresents sampling plans and specifications for pharmaceutical products which are used in judging the quality of these products. Previously accepted and revised sampling plans for product dissolution are evaluated and compared using conventional statistical techniques and computer simulation. This paper presents operating characteristic curves and related graphs for these dissolution sampling plans that form a basis upon which lots of dosage units are accepted or rejected. These plans have also been evaluated for their effectiveness in assuring the quality of drug products.
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