Test for batch-to-batch variation in stability analysis.
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.
Chow
S C
SC
Biometrics Department, Parke-Davis Pharmaceutical Research Division, Warner-Lambert Co., Ann Arbor, MI 48105.
Shao
J
J
D004345:Drug Industry / Q000379:methods; D004355:Drug Stability; D013223:Statistics as Topic