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proper statistical evaluation of the results of the AMT measured against predeter-
mined acceptance criteria as outlined in the AMT protocol is critical to the process
to ensure method success upon implementation in the receiving laboratory.
reFerences
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2. PhRMA Analytical Research and Development Workshop , Wilmington, DC, September
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3. Scypinski, S., Roberts, D., Oates, M., and Etse, J., Pharm. Technol. , March 2002, p. 84.
4. Mcgonigle, E., Assay validation and interlaboratory transfer in Development and
Validation of Analytical Methods , Riley, C. M. and Rosanske, T. W., Editors, Elsevier,
New York, 1996, p. 3.
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Analysis , Ahuja, S. and Scypinski, S., Editors, Academic Press, San Diego, CA, 2001,
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6. Lister, A.S., in Handbook of Pharmaceutical Analysis by HPLC , Ahuja, S. and Dong,
M., Editors, Elsevier, New York, 2005, p. 212.
7. Snyder, L. R., Kirkland, J. J., and Glajch, J. L., Chapter 15: Completing the method:
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New York, 1997, p. 685.
8. Etse, J., Am. Pharm. Rev. , January/February, 8(1), 74, 2005.
9. The United States Pharmacopeia 34/National Formulary 29 , The United States
Pharmacopeia Convention, Inc., Rockville, MD, 2011, Chapter <1225>.
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tion of analytical procedures, text and methodology, Q2(R1), November 2005. See
www.ICH.org.
11. Swartz, M. and Krull, I., Method Validation and Robustness. LCGC 24(5), 480,
May 2006.
12. Swartz, M., Analytical Instrument Qualification. Pharmaceutical Technology Special
Supplement , July 2006, p. 12.
13. Miller, J. C. and Miller, J. N., Statistics for Analytical Chemistry , Ellis Horwood
Publishers, Chichester, UK, 1986.
14. NIST/SEMATECH e-Handbook of Statistical Methods , http://www.itl.nist.gov/div898/
handbook.
15. Meier, P. C. and Zund, R. E., Statistical Methods in Analytical Chemistry , John Wiley &
Sons, New York, 1993.
16. Snyder, L. R., Kirkland, J. J., and Glajch, J. L., Practical HPLC Method Development ,
John Wiley & Sons, New York, 1997.
17. M. Swartz, unpublished data.
18. Pappa, H. and Marques, M., Presentation at USP Annual Scientific Meeting , Denver,
September 28, 2006. See also http://www.usp.org/USPNF/columns.html.
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