Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE)

Journal of Pharmaceutical and Biomedical Analysis

Volumn 39, Issue 1-2, 2005, Pages 310-314

  Schepers, U ^a   Watzig H ^a  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

Author keywords

Acceptance criteria; Accuracy; Analytical method transfer; Equivalence test; ISPE; Pharmaceutical; Quality control; Simulation

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; EQUIVALENCE TEST; ORGANIZATION; PHARMACEUTICAL ENGINEERING; PRIORITY JOURNAL; PROBABILITY; QUALITY CONTROL; SIMULATION; STATISTICAL ANALYSIS;

CHEMISTRY, PHARMACEUTICAL; SOCIETIES; SOFTWARE;

EID: 23444451264     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2005.03.015     Document Type: Article

References (6)

1. ISPE Good Practice Guide for Technology Transfer available at http://www.ispe.org/.
2. USP 〈1010〉 Analytical Data - Interpretation and Treatment, Pharmacopeial Forum 30 (2004) 236-263.
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4. C. Hartmann, J. Smeyers-Verbeke, W. Penninckx, Y. Vander Heyden, P. Vankeerberghen, and D.L. Massart Anal. Chem. 67 1995 4491 4499
5. U. Schepers, J. Ermer, L. Preu, and H. Wätzig J. Chromatogr. B 810 2004 111 118
6. MVA - Method Validation in Analytics, 2001, NOVIA GmbH, Frankfurt, Germany, available at http://www.novia.de/.