Guidance for robustness/ruggedness tests in method validation

Journal of Pharmaceutical and Biomedical Analysis

Volumn 24, Issue 5-6, 2001, Pages 723-753

  Vander Heyden, Y ^a   Nijhuis, A ^b   Smeyers Verbeke, J ^a   Vandeginste, B G M ^b   Massart, D L ^a  

^a PHARMACEUTICAL INSTITUTE   (Belgium)

^b UNILEVER RESEARCH VLAARDINGEN   (Netherlands)

Author keywords

Method development; Method validation; Robustness test; Ruggedness test; System suitability limits

Indexed keywords

ANALYTIC METHOD; CONFERENCE PAPER; DRUG INDUSTRY; EVALUATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REPRODUCIBILITY; VALIDATION PROCESS;

CHEMISTRY, PHARMACEUTICAL; METHODS;

EID: 0035089518     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0731-7085(00)00529-X     Document Type: Conference Paper

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