Application of the equivalence test for analytical method transfers: Testing precision using the United States Pharmacopoeia concept 〈1 0 1 0〉

Journal of Pharmaceutical and Biomedical Analysis

Volumn 41, Issue 1, 2006, Pages 290-292

  Schepers, U ^a   Watzig H ^a  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

Author keywords

Acceptance criteria; Analytical method transfer; Equivalence test; Pharmaceutical; Precision; Quality control; Simulation; Statistic; USP 1 0 1 0

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; MATHEMATICAL ANALYSIS; MEASUREMENT; MEDICAL LITERATURE; POWER ANALYSIS; PRIORITY JOURNAL; SAMPLE SIZE;

CHEMISTRY, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; MODELS, STATISTICAL; MODELS, THEORETICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; UNITED STATES;

EID: 33645049833     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2005.10.030     Document Type: Article

References (5)

1. J. Ermer, and J.H.McB. Miller Method Validation in Pharmaceutical Analysis 2005 Wiley-VCH Verlag GmbH & Co. KGaA Weinheim (Germany) pp. 281-300
2. U. Schepers, and H. Wätzig J. Pharm. Biomed. Anal. 39 2005 310 314
3. ISPE Good Practice Guide for Technology Transfer available at www.ispe.org.
4. D.L. Massart, B.G.M. Vandeginste, L.M.C. Buydens, S. De Jong, P.J. Lewi, and J. Smeyers-Verbeke Handbook of Chemometrics and Qualimetrics Part A 1997 Elsevier Amsterdam p. 104
5. USP 28-NF 23, General Chapter (1010), 2005.