Revision of the Dissolution Procedure: Development and Validation <1092>

被引：1
|
作者：
Skwierczynski, R. [1 ]
Curry, P.
Gray, V.
Kraemer, J.
Stippler, E.
Suggett, J.
Mirza, T. [1 ]
Brown, W. [1 ]
机构：
[1] US Pharmacopeial Convent Inc, Rockville, MD 20852 USA
来源：
DISSOLUTION TECHNOLOGIES | 2014年 / 21卷 / 01期
关键词：
D O I：
10.14227/DT210114P6
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
In this Stimuli article a Subcommittee of the Pharmaceutical Dosage Forms Expert Committee discusses a proposed revision to general information chapter The Dissolution Procedure: Development and Validation < 1092 >. Published elsewhere in this issue of PF, the proposed revision provides a new structure that divides the process of development and validation of the dissolution test into its component parts. The revision adds sections about preliminary assessments needed before initiating method development and about automation. A new section, Interpretation, within Acceptance Criteria clarifies the interpretation of results from the dissolution test. The relationship between bioavailability, bioequivalence, and the dissolution test is considered in general chapter Assessment of Drug Product Performance-Bioavailability, Bioequivalence, and Dissolution < 1090 >.
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页码：6 / 8
页数：3
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