Validation of assays for use with combination vaccines

Biologicals

Volumn 27, Issue 1, 1999, Pages 35-41

  Klein, James ^a   Capen, Robert ^a   Mancinelli, Ralph ^a   Robinett, Robin ^a   Pietrobon, Patricia J Freda ^b   Quinn, Joe ^b   Schofield, Tim ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Pasteur Merieux Connaught   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN; VACCINE;

ACCURACY; ANALYTIC METHOD; ARTICLE; ASSAY; CONTROLLED STUDY; DRUG RELEASE; DRUG STABILITY; HUMAN; LABORATORY TEST; METHODOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; STATISTICAL ANALYSIS; VALIDATION PROCESS; VARIANCE;

EID: 0032788848     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1006/biol.1999.0167     Document Type: Article

References (5)

1. ICH Harmonized Tripartite Guideline, "Validation of Analytical Procedures", Recommended for Adoption at Step 4 of the ICH Process on 27 October 1994 by the ICH Steering Committee, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
2. ICH Harmonized Tripartite Guideline, "Validation of Analytical Procedures: Methodology", Recommended for Adoption at Step 4 of the ICH Process on 6 November 1996 by the ICH Steering Committee, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
3. Burdick RK, Graybill FA. Confidence Intervals on Variance Components. 1992;Marcel Dekker, Inc. New York.
4. Finney DJ. Statistical Method in Biological Assay. 2nd Edn. 1964;Hafner Publishing Co. New York.
5. Montgomery DC. Introduction to Statistical Quality Control. 2nd Edn. 1991;John Wiley & Sons, New York.