Introduction: National and international guidelines

LC GC: Liquid Chromatography, Gas Chromatography

Volumn 15, Issue 6, 1997, Pages 534-540

  Krull, Ira ^a   Swartz, Michael ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0000806148     PISSN: 08889090     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. M.E. Swartz and I.S. Krull, Analytical Method Development and Validation (Marcel Dekker, New York, 1997).
2. U.S. Pharmacopeia XXIII/National Formulary XVIII (United States Pharmacopeial Convention, Rockville, Maryland, 1995), chapter 〈1225〉, pp. 1982-1984.
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Background and Status of Harmonization (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, November 1996). ICH Secretariat, c/o IFPMA, 30 rue de St.-Jean, P.O. Box 9, 1211 Geneva 18. Switzerland, or at www.pharmweb.net.
4. ICH-Q2A Text on Validation of Analytical Procedures (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, March 1995), Geneva.
5. ICH-Q2B Validation of Analytical Procedures: Methodology (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, November 1996), Geneva.
6. Guidance for Method Development and Validation for the Resource Conservation and Recovery Act Program (U.S. Environmental Protection Agency, Washington, D.C., 1995).
7. C.M. Riley and T.W. Rosanske, Eds., Development and Validation of Analytical Methods. Progress in Pharmaceutical and Biomedical Analysis (Pergamon Press/Elsevier, Tarrytown, New York, 1996).
8. R.J. Bopp, T.J. Wozniak, S.L. Antiker, and J. Palmer, in Pharmaceutical and Biomedical Applications of Liquid Chromatography, C.M. Riley, W.J Lough, and I.W. Wainer, Eds. (Pergamon Press/Elsevier, Tarrytown, New York, 1994), pp. 315-344.
9. M.J. Green, Anal. Chem. 68(9), 305A-309A (1996).
10. Guideline for Submitting Samples and Analytical Data for Methods Validation (U.S. Food and Drug Administration, U.S. Government Printing Office, 1990-281-794:20818, February 1997).
11. U.S. Pharmacopeia XXIII/National Formulary XVIII (United States Pharmacopeial Convention, Rockville, Maryland, 1995), chapter 〈621〉, pp. 1776-1777.
12. U.S. Pharmacopeia XXII/National Formulary XVII (United States Pharmacopeial Convention, Rockville, Maryland, 1990), pp. 1710-1712.