Analytical methodology transfer

Separation Science and Technology

Volumn 3, Issue C, 2001, Pages 485-497

  Scypinski, Stephen ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33845266190     PISSN: 18771718     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0149-6395(01)80016-7     Document Type: Book

References (17)

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2. Pharmaceutical Research and Manufacturers Association Analytical Research and Development Workshop, Wilmington, DE, September 20, 2000
3. Scypinski, S., Oates, M., Etse, J., and Roberts, D. PhRMA acceptable analytical practice on technology transfer. Work in progress.
4. Crowther, J. B. International method transfers. Presented at the 1998 Eastern Analytical Symposium and Exposition, Abstract 490, 1998.
5. Crowther, J. B., Jimidar, M. L, Niemeijer, N., and Salomons, P. Qualification of laboratory instrumentation, validation, and transfer of analytical methods. In Analytical Chemistry in a GMP Environment (J. M. Miller and J. B. Crowther, Eds.), pp. 453-456. Wiley, New York, 2000.
6. Howard, B. Experiences and expectations for transferring automated pharmaceutical analysis methods in a global pharmaceutical company. In Proceedings of the 1999 International Symposium on Laboratory Automation and Robotics, CD-ROM version, ISLAR, Hopkinton, MA, 1999.
7. Kirschbaum, J. J. Inter-laboratory transfer of HPLC methods: problems and solutions. J. Pharm. Biomed. Anal. 7:813-833, 1989.
8. Bidlingmeyer, B. A. Practical HPLC Methodology and Applications. Wiley, New York, 1992.
9. Ethinyl Estradiol. In USP 24-NF 19, pp. 692-693. U.S. Pharmacopeial Convention, Rockville, MD, 2000.
10. Crowther, J. B., Salomons, P., and Callaghan, C. Analytical method development for assay and impurity determination in drug substances and drug products. In Analytical Chemistry in a GMP Environment (J. M. Miller and J. B. Crowther, Eds.), pp. 350-351. Wiley, New York, 2000.
11. Kassal, A., Szecsi, A., Koppany, A., Vegh, Z., and Ferenczi-Fodor, K. Analytical transfer of an OPLC purity test and its application for in-process monitoring. J. Planar Chromatogr. 13:30-32,2000.
12. Meier, P. C. and Zund, R. E. Statistical Methods in Analytical Chemistry. Wiley, New York, 1993.
13. Taylor, J. K. Statistical Techniques for Data Analysis. Lewis, New York, 1990.
14. Anderson, S. and Hauck, W. W. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Commun. Statist. Theory Methods 12:2663-2692, 1983.
15. Vial, J., Jardy, A., Anger, P., Brun, A., and Menet, J. Methodology for transfer of liquid chromatographic methods based on statistical considerations. J. Chromatogr. A 815:173-182,1998.
16. Miller, J. M. The training of pharmaceutical analysts. Am. Lab. 32(20):13-19, 2000.
17. Miller, J. M. and Crowther, J. B. Analytical Chemistry in a GMP Environment. Wiley, New York, 2000.