An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: Progresses and limitations

Journal of Pharmaceutical and Biomedical Analysis

Volumn 32, Issue 4-5, 2003, Pages 753-765

  Boulanger, B ^a   Chiap, P ^b   Dewe, W ^a   Crommen, J ^b   Hubert, Ph ^b  

^a Eli Lilly Benelux   (Belgium)

^b UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Bioanalysis; Method validation; Statistics

Indexed keywords

ACCURACY; ANALYTIC METHOD; CALIBRATION; CHROMATOGRAPHY; CONFERENCE PAPER; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; VALIDATION PROCESS;

EID: 0042625050     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0731-7085(03)00182-1     Document Type: Conference Paper

References (19)

1. Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., McDowall R.D., Pittman K.A., Spector S. Pharm. Res. 9:1992;588-592.
2. International Conference on Harmonization. Fed. Regist. 60:1995;11260-11262.
3. International Conference on Harmonization. Fed. Regist. 62:1997;27463-27467.
4. Chapuzet E., Mercier N., Bervoas-Martin S., Boulanger B., Chevalier P., Chiap P., Grandjean D., Hubert Ph., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C. S.T.P. Pharm. Pratiq. 7:1997;169-194.
5. Chapuzet E., Mercier N., Bervoas-Martin S., Boulanger B., Chevalier P., Chiap P., Grandjean D., Hubert Ph., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C. S.T.P. Pharm. Pratiq. 8:1998;81-107.
6. Chiap P., Hubert Ph., Boulanger B., Crommen J. Anal. Chim. Acta. 391:1999;227-238.
7. Hubert P., Chiap Ph., Crommen J., Boulanger B., Chapuzet E., Mercier N., Bervoas-Martin S., Chevalier P., Grandjean D., Lagorce P., Lallier M., Laparra M.C., Laurentie M., Nivet J.C. Anal. Chim. Acta. 391:1999;135-148.
8. Smith W.C., Sittampalam G.S. J. Biopharm. Statistics. 8:1998;509-532.
9. Kringle R.O. Pharm. Res. 11:1994;556-560.
10. R. Kringle, R. Khan-Malek, Statistical intervals for nested random samples in assay validation, Midwest Biopharmaceutical Statistics Workshop, Muncie, IN, May 24, 1994.
11. Hartmann C., Smeyers-Verbeke J., Pennick W. XX, Van der Heyden Y., Vankeerberghen P., Massart D.L. Anal. Chem. 67:1995;4491-4499.
12. Schuirmann D.J. J. Pharmacokin. Biopharm. 15:1987;657-680.
13. Hartmann C., Massart D.L., McDowall R.D. J. Pharm. Biomed. Anal. 12:1994;1337-1343.
14. Searle S.R., Casella G., McCulloch C.E. Variance Components. 1992;Wiley, New York.
15. Satterthwaite F.E. Biometr. Bull. 2:1946;110-114.
16. Atkinson A.C., Donev A.N. Optimum Experimental Design. 1992;Oxford University Press, Oxford.
17. Rocke D.M., Jones G. Technometrics. 39:1997;162-170.
18. Explanatory Note EEC III/844/87 EN-Final, August 1989.
19. Chow S.-C., Liu J.-P. Statistical design and analysis in pharmaceutical sciences: validation, process controls and stability. Statistics Textbooks and Monographs. 143:1995;Marcel Dekker, New York.