Méthodes chromatographiques de dosage dans les milieux biologiques Exemple d'application de la stratégie de validation Rapport d'une commission SFSTP

S.T.P. Pharma Pratiques

Volumn 8, Issue 2, 1998, Pages 81-107

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

^a Societe Francaise des Sciences et Techniques Pharmaceutiques   (France)

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; DRUG BLOOD LEVEL; DRUG DETERMINATION; LIQUID CHROMATOGRAPHY; REPRODUCIBILITY; REVIEW; STATISTICAL ANALYSIS; VALIDATION PROCESS;

EID: 0031807569     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (5)

1. CHAPUZET E. et MERCIER N. - Méthodes chromatographiques de dosage dans les milieux biologiques: stratégie de validation. Rapport d'une commission SFSTP. - STP Pharma Prat., 7, 169-194, 1997.
2. CHIAP P., CECCATO A., MIRALLES-BURAGLIA B., BOULANGER B., HUBERT P. et CROMMEN J. - Poster présenté au XXIst International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC 97), Birmingham, Royaume-Uni, 22-27 juin 1997.
3. CHIAP P., CECCATO A., MIRALLES-BURAGLIA B., BOULANGER B., HUBERT P. et CROMMEN J. - Development and validation of an automated liquid chromatography determination of sotalol in plasma using dialysis combined with the enrichment of the dialysate on a cation-exchange pre-column as on-line sample preparation. - A paraître.
4. CHOW S.C. et LIU J.P. Eds. - 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.