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Test for batch‐to‐batch variation in stability analysis
Author(s) -
Chow SheinChung,
Shao Jun
Publication year - 1989
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780080712
Subject(s) - stability (learning theory) , computer science , variation (astronomy) , statistics , statistical analysis , mathematics , machine learning , physics , astrophysics
We propose several statistical tests for batch‐to‐batch variation in the stability analysis of a drug product and present applications with data from new drug application stability and marketing stability analyses.