Analytical method transfer

LCGC North America

Volumn 24, Issue 11, 2006, Pages 1204-1214

  Swartz, Michael ^a   Krull, Ira ^b  

^a WATERS CORPORATION   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33845238727     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

1. ISPE Good Practice Guide: Technology Transfer, (ISPE, Tampa, Florida, 2003).
2. PhRMA Analytical Research and Development Workshop, Wilmington, Delaware, 20 September, 2000.
3. S. Scypinski, D. Roberts, M. Oates, and J. Etse, Pharm. Tech., 28(3) 84 (2004).
4. E. Mcgonigle, "Assay Validation and Interlaboratory Transfer'" in Development and Validation of Analytical Methods, C.M. Riley and T.W. Rosanske, Eds. (Elsevier, New York, 1996), p. 3.
5. S. Scypinski, "Analytical Method Transfer," in Handbook of Modern Pharmaceutical Analysis, S. Ahuja and S. Scypinski, Eds. (Academic Press, San Diego, California, 2001), p. 485.
6. A.S, Lister, in Handbook of Pharmaceutical Analysis by HPLC, S. Ahuja and M. Dong, Eds. (Elsevier, New York, 2005), p. 212.
7. L.R. Snyder, J.J. Kirkland, and J.L. Glajch, chapter 15 in Practical HPLC Method Development (John Wiley and Sons, New York, 1997), p. 685.
8. J. Etse, Amer. Pharm. Rev. 8(1), 74 (2005).
9. USP 29, 2006, Chapter 1225, pp. 3050-3053.
10. International Conference on Harmonization, Harmonized Tripartite Guideline, Validation of Analytical Procedures, Text and Methodology, Q2(R1), November 2005, See www.ICH.org.
11. M. Swartz and I. Krull, LCGC 24(5), 480 (2006).
12. M. Swartz, Pharm. Techn. Special Supplement, 12 (June 2006).
13. J.C. Miller and J.N. Miller, 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. P.C. Meier and R.E. Zund, Statistical Methods in Analytical Chemistry (John Wiley and Sons, New York, 1993).
16. L.R. Snyder, J.J. Kirkland, and J.L. Glajch, Practical HPLC Method Development (John Wiley and Sons, New York, 1997).
17. M. Swartz and R. Plumb, unpublished results.
18. H. Pappa and M. Marques, presentations at USP Annual Scientific Meeting, Denver, 28 September 2006.