Frequently asked questions about analytical method validation

LC GC: Liquid Chromatography, Gas Chromatography

Volumn 16, Issue 5, 1998, Pages 464-467

  Krull, Ira ^a   Swartz, Michael ^b  

^a NORTHEASTERN UNIVERSITY   (United States)

^b WATERS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0005401932     PISSN: 08889090     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (10)

1. Validation of Analytical Procedures, Terms and Definitions (International Coonference on Harmonization of Technical Requirements for Registration of Pharmaceuticals in Human Use, ICH-Q2A, Geneva, Switzerland, March 1995).
2. I.S. Krull and M.E. Swartz, LC·GC 15(6), 534-540 (1997).
3. I.S. Krull and M.E. Swartz, LC·GC 15(9), 842-845 (1997).
4. U.S. Pharmacopeia, National Formulary, USP 23, NF 18 (United States Pharmacopeial Convention, Inc., Rockville, Maryland, 1995), pp. 3-4.
5. J.P. Boehlert, personal communication, September 1997.
6. "FDA System Suitability Workshop," presented in Nutley, New Jersey, June 1997.
7. Steven S. Kuwahara, BioQuality 2(7), 3-4 (1997).
8. B. Furman, personal communication, January 1998.
9. V.P. Shah, J. Pharm. Sci. 81, 309-312 (1992).
10. A.C. Cartwright, Drug Inf. J. 25, 471-482 (1991).