Comparison of the recovery spread in analytical development and routine quality control-Based on the ICH quality guideline Q2B

Journal of Pharmaceutical and Biomedical Analysis

Volumn 43, Issue 2, 2007, Pages 708-710

  Schepers, U ^a   El Deeb, S ^a   Ermer, J ^b   Watzig H ^a  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

^b SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

Author keywords

Accuracy; Confidence interval; ICH Q2B; Permutation; Quality control

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; DATA ANALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTERNATIONAL CONFERENCE ON HARMONIZATION; INTERNATIONAL COOPERATION; LIQUID CHROMATOGRAPHY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; STANDARD; STATISTICAL PARAMETERS;

CHEMISTRY, ANALYTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; COMPUTER SIMULATION; GLYBURIDE; GUIDELINES; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 33845616859     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.07.012     Document Type: Article

References (4)

1. Q2B: Validation of Analytical Procedures: Methodology, 1996 (available under: http://www.fda.gov/cder/guidance/1320fnl.pdf).
2. Ermer J., and McB. Miller J.H. Method Validation in Pharmaceutical Analysis: A Guide to Best Practice. first ed. (2005), WILEY-VCH, GmbH & Co. KGaA, Weinheim pp. 205-208
3. Schepers U., Ermer J., Preu L., and Wätzig H. J. Chromatogr. B 810 (2004) 111-118
4. Massart D.L., Vandeginste B.G.M., Buydens L.M.C., De Jong S., Lewi P.J., and Smeyers-Verbeke J. Handbook of Chemometrics and Qualimetrics Part A. first ed. (1997), Elsevier, Amsterdam pp. 58-63