Method validation protocol - Required data elements, method transfer, and revalidation

LC GC: Liquid Chromatography, Gas Chromatography

Volumn 15, Issue 9, 1997, Pages 842-845

  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: 0005483629     PISSN: 08889090     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. I.S. Krull and M.E. Swartz, LC·GC 15(6), 534-540 (1997).
2. U.S. Pharmacopeia 23/National Formulary 18 (United States Pharmacopeial Convention, Rockville, Maryland, 1995), chapter 〈1225〉, pp. 1982-1984.
3. Guideline on Method Validation Methodology (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, November 1996).
4. Center for Drug Evaluation and Research, Reviewer Guidance: Validation of Chromatographic Methods (U.S. Government Printing Office, publication number 615-023-1302/02757, Washington, D.C., 1994).
5. U.S. Pharmacopeia 23/National Formulary 18 (United States Pharmacopeial Convention, Rockville, Maryland, 1995), chapter 〈621〉, pp. 1776-1777.