A strategy for validation of bioanalytical methods

Journal of Pharmaceutical and Biomedical Analysis

Volumn 14, Issue 4, 1996, Pages 375-388

  Braggio, S ^a   Barnaby, R J ^a   Grossi, P ^a   Cugola, M ^a  

^a GSK   (Italy)

Author keywords

Bioanalytical methods; Drug development; Validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; AUTOMATION; DRUG DEVELOPMENT; DRUG STABILITY; PRIORITY JOURNAL; QUALITY CONTROL; RADIOIMMUNOASSAY; SHORT SURVEY; STANDARD; TECHNIQUE;

EID: 0029893819     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/0731-7085(95)01644-9     Document Type: Article

References (20)

1. C.C. Peck, J. Clin. Pharmacol., 34 (1994) 11-119.
2. D.A. Smith, K. Beaumont, N.J. Cussans, M.J. Humphrey, S.G. Jezequel, D.J. Rance, D.A. Stopher and D.K. Walker, Xenobiotica, 22 (1992) 195-205.
3. V.P. Shah, K.K. Midha, S. Dighe, I.J. McGilveray, J.P. Skelly, A. Yacobi, T. Layloff, C.T. Viswanathan, C.E. Cook, R.D. McDowall, K.A. Pittmnan and S. Spector, Eur. J. Drug Metab. Pharmacokin., 16 (1991) 249-255.
4. A.R. Buick, M.V. Doig, S.C. Jeal, G.S. Land and R.D. McDowall, J. Pharm. Biomed. Anal., 8 (1990) 629-637.
5. A.G. Causey, H.M. Hills and L.J. Phillips, J. Pharm. Biomed. Anal., 8 (1990) 625-628.
6. International Organisation for standardisation in Statistical Methods. ISO Standards Handbook 3, 3rd edn., 1989.
7. C. Hartmann, D.L. Massart and R.D. McDowall, J. Pharm. Biomed. Anal., 12 (1994) 1337-1343.
8. H.T. Karnes, G. Shiu and V.P. Shah, Pharm. Res., 8 (1991) 421-426.
9. C.P.M.P Notes of Guidance: Analytical validation, The Rules governing Medicinal Products in the European Community, Addendum 3, European Communities Commission Luxembourg.
10. F. Jamali, Pharmacology, 32 (1992) 930-934.
11. R.W. Abbot, G.D. Allen and G. Rhodes, in E. Reids, H.M. Hill and I.D. Wilson (Eds.), Biofluids and Tissue Analysis for Drugs, Vol 23 The Royal Society of Chemistry, 1994, pp 255-256.
12. R.R. Walters and C.Y. Hsu, Chirality, 6 (2) (1994) 105-115.
13. A. Marzo, Boll. Chimi. Farma., 132 (8) (1993) 267-271.
14. H. Fieger, J. Iredale and I.W. Wainer, Chirality, 5 (2) (1993) 65-70.
15. T.J. Wozniak, R.J. Bopp and E.C. Jensen, J. Pharm. Biomed. Anal., 9 (1991) 363-382.
16. J.R. Lang and S. Bolton, J. Pharm. Biomed. Anal., 9 (1991) 357-361.
17. J.R. Lang and S. Bolton, J. Pharm. Biomed. Anal., 9 (1991) 435-442.
18. A.C. Cartwright, Drug Inf. J., 25 (1991) 471-482.
19. B.S. Chakraborty, E.M. Hawes, Rosenthaler and K.K. Midha, Ther. Drug Monit., 9 (1987) 227-235.
20. R. Rahmani, P. Gil, M. Martin, A. Durand, J. Barbet and J.P. Cano, J. Pharm. Biomed. Anal., 1 (1983) 301-309.