A practical guide to analytical method validation

Analytical Chemistry

Volumn 68, Issue 9, 1996, Pages

  Mark Green, J ^a  

^a DUPONT COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0001229909     PISSN: 00032700     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. U.S. Pharmacopeia 23, pp. 1982-84, United States Pharmacopeial Convention, Inc., 1994.
2. International Conference on Harmonisation, Draft Guideline on Validation of Analytical Procedures: Definitions and Terminology, Federal Register, Volume 60, pp. 11260, March 1, 1995.
3. Reviewer Guidance, Validation of Chromatographic Methods, Center for Drug Evaluation and Research, Food and Drug Administration, 1994.
4. Guideline for Submitting Samples and Analytical Data for Methods Validation, Food and Drug Administration, 1987.
5. Clarke, G. S. J. Pharm. Biomed. Anal. 1994, 12, 643.
6. Inman, E. L.; Frischman, J. K.; Jimenez, P. J.; Winkel, G. D.; Persinger, M. L.; Rutherford, B. S. J. Chromatogr. Sci. 1987, 25, 252.
7. Wilson, T. D. J. Pharm. Biomed. Anal. 1990, 8, 389.
8. Adamovics, J. A., Chromatographic Analysis of Pharmaceuticals, M. Dekker, New York, 1990.
9. Hokanson, G. C. Pharm. Technol. 1994, 18, 118.
10. Carr. G. P.; Wahlich, J. C. J. Pharm. Biomed. Anal. 1990, 8, 613.
11. Cassidy, R.; Janoski, M. LC-GC 1992, 10, 692.
12. Dorschel, C. A.; Ekmanis, J. L.; Oberholtzer, J. E.; Warren, F. V.; Bidlingmeyer, B. A. Anal. Chem 1989, 61, 951 A.
13. Virlichie, J. L.; Ayache, A. S.T.P. Pharma Pratiques 1995, 5, 37.