Implementing new technology in a regulated environment

LCGC North America

Volumn 24, Issue 8, 2006, Pages 770-775

  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: 33751205604     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (17)

1. M.E. Swartz and I.S. Krull, LCGC 23(10), 1100-1109 (2005).
2. Pharmacopeial Forum, 31(2), 555 (Mar.-Apr. 2005).
3. FDA ORA Laboratory Procedure, #ORA-LAB.5.4.5, Revised 09/09/2005. See also: http://www.fda.gov/ora/science_ref/lm/vol2/section/5_04_05.pdf
4. Guidance for Industry, Changes to an Approved NDA or ANDA, PDA Center for Drug Evaluation and Research, Rockville MD, April 2004. See also: http://www.fda.gov/cder/guidance/index.htm
5. Guidance for Industry, Comparability Protocols-Chemistry, Manufacturing, and Controls Information, PDA Center for Drug Evaluation and Research, Rockville, Maryland, February 2003. See also: http://www.fda.gov/cder/guidance/ index.htm
6. W.B. Furman, J.G. Dorsey, and L.R. Snyder, Pharm. Technol. 22(6), 58-64 (1998).
7. Pharmacopeial Forum, 31(3), 825 (May-June 2005).
8. Pharmacopeial Forum, 31(6), 1681 (Nov.-Dec 2005).
9. M.E. Swartz, unpublished data on the analysis of tricyclic amines at pH 7.2.
10. M.E. Swartz and I.S. Krull, LCGC 23(6), 46 (2005).
11. M.E. Swartz, J. Liq. Chrom. & Rel. Technol. 28(7-8), 1253-1263 (2005).
12. Separation Science Redefined, Supplement to LCGC, May 2005.
13. J. Mazzeo, U. Neue, M. Kele, and R. Plumb, Anal. Chem. 277(23), 460A-467A (2005).
14. Pharmacopeial Forum 31(2), 637 (March-April 2005).
15. Pharmacopeial Forum 32(3), 833 (May-June 2006).
16. M.E. Swartz and I.S. Krull, LCGC 23(6), 26 (2004).
17. Guidance for Industry, Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (U.S. Food and Drug Administration, Department of Health and Human Services, Rockville, Maryland, September 1998).