Establishment of an Equivalence Acceptance Criterion for Accelerated Stability Studies

In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2013-07, Vol.23 (4), p.730-743
Main Authors: Burdick, Richard K., Sidor, Leslie
Format: Article
Language:English
Subjects:
Accelerated stability study
Acceptance
Acceptance tests
Biopharmaceutics - standards
Biopharmaceutics - statistics & numerical data
Computer Simulation
Criteria
Drug Stability
Drug Storage - standards
Drug Storage - statistics & numerical data
Drugs
Effectiveness
Equivalence
Equivalence testing
Models, Statistical
Product safety
Profile data
Research Design - statistics & numerical data
Specifications
Stability
Statistical tests
Statistics
Studies
Therapeutic Equivalency
Time Factors
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Description
Summary:In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543406.2013.789891