Example of application of the new strategy proposed for the validation of chromatographic bioanalytical methods

S.T.P. Pharma Pratiques

Volumn 10, Issue 2, 2000, Pages 79-101

  Chapuzet, E ^a   Mercier, N ^a   Bervoas Martin, S ^a   Boulanger, B ^a   Chevalier, P ^a   Chiap, P ^a   Grandjean, D ^a   Hubert, Ph ^a   Lagorce, P ^a   Lallier, M ^a   Laparra, M C ^a   Laurentie, M ^a   Nivet, J C ^a  

^a NONE

Author keywords

Absolute recovery; Accuracy; Bioanalysis; Experimental design; Limits of detection and quantitation; Linearity; Precision; Response function; Selectivity; Specificity; Statistics; Validation

Indexed keywords

ATENOLOL; SOTALOL;

ACCURACY; ARTICLE; DRUG DETERMINATION; LIQUID CHROMATOGRAPHY; QUALITY CONTROL; STATISTICAL ANALYSIS; VALIDATION PROCESS;

EID: 6744219597     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. CHAPUZET E , MERCIER N - New strategy for the validation of Chromatographic bioanalytical methods. - STP Pharma Prat., 10, 12-27, 2000.
2. CHIAP P., CECCATO A., MIRALLES-BURAGLIA B., BOLLANGER B., HUBERT PH., CROMMEN J. - Poster presented at the XXIst International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC '97), Birmingham. June 22-27, 1997.
3. CHIAP P., CECCATO A., MIRALLES-BURAGLIA B., BOULANGER B., HUBERT PH., CROMMEN J. - Development and validation of an automated method for the liquid chromatographic determination of sotalol in plasma using dialysis and trace enrichment on a cation-exchange precolumn as on-line sample preparation. - J. Pharm. Biomed. Anal , submitted for publication.
4. CHOW S.-C AND LIU J.-P. - Statistical Design and Analysis in Pharmaceutical Sciences: Validation, Process Controls and Stability. - Statistics Textbooks and Monographs, Vol. 143, Marcel Dekker, NYC, 1995.
5. LEVENE H. - Robust test for equality of variances. - In: Contributions to Probability and Statistics, I. Olkin Ed., Stanford University Press, 1960, p. 278.