Analytical method transfer using equivalence tests with reasonable acceptance criteria and appropriate effort: Extension of the ISPE concept

Journal of Pharmaceutical and Biomedical Analysis

Volumn 53, Issue 5, 2010, Pages 1124-1129

  Kaminski, L ^a   Schepers, U ^a   Watzig H ^a  

^a TECHNICAL UNIVERSITY OF BRAUNSCHWEIG   (Germany)

Author keywords

Acceptance criteria; Equivalence test; ISPE; Method transfer

Indexed keywords

ANALYTIC METHOD; BIOEQUIVALENCE; CONFIDENCE INTERVAL; DECISION MAKING; EXPERIMENTAL DESIGN; LABORATORY; NULL HYPOTHESIS; PRIORITY JOURNAL; PROBABILITY SAMPLE; QUANTITATIVE ANALYSIS; REVIEW; STUDENT T TEST; WORKLOAD;

ANIMALS; BIOMEDICAL ENGINEERING; CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 77955918009     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.04.034     Document Type: Review

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