Analytical method transfer: New descriptive approach for acceptance criteria definition

Journal of Pharmaceutical and Biomedical Analysis

Volumn 46, Issue 1, 2008, Pages 104-112

  de Fontenay, Gérald ^a  

^a Pharmaceutical Analysis Avogadro ^*  (France)

Author keywords

Acceptance criteria; Analytical method transfer; HPLC assay; Method capability; Monte Carlo simulations for risk analysis

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; CRITERION VARIABLE; DESCRIPTIVE RESEARCH; PRIORITY JOURNAL; PROBABILITY; RISK ASSESSMENT; SIMULATION; STATISTICAL ANALYSIS;

CHEMISTRY, ANALYTICAL; DRUG INDUSTRY; MONTE CARLO METHOD; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; TECHNOLOGY, PHARMACEUTICAL;

EID: 36849063184     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.09.007     Document Type: Article

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