Power of analysis of variance for assessing batch-variation of stability data of pharmaceuticals

Chemical and Pharmaceutical Bulletin

Volumn 44, Issue 10, 1996, Pages 1948-1950

  Yoshioka, Sumie ^a   Aso, Yukio ^a   Kojima, Shigeo ^a   Li Wan Po, Alain ^b  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

analysis of variance; batch variation; shelf life; significance level; stability

Indexed keywords

ARTICLE; DRUG STABILITY; DRUG STORAGE; PHARMACY; STATISTICAL ANALYSIS; SYSTEM ANALYSIS;

EID: 0029830506     PISSN: 00092363     EISSN: None     Source Type: Journal    
DOI: 10.1248/cpb.44.1948     Document Type: Article

References (3)

1. ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use) Harmonised Tripartite Guideline for Sability Testing of New Drug Substances and Products (October 1993).
2. Woolfe A. J., Worthington H.E.C., Drug Dev. Communication, 1, 185-210 (1974-1975).
3. Winer B. J., "Statistical Principle in Experimental Design," McGraw-Hill Kogakusha, Ltd., Tokyo, 1971, p. 431.