Statistical method for the determination of equivalence of automated test procedures

Journal of Automated Methods and Management in Chemistry

Volumn 25, Issue 6, 2003, Pages 123-127

  Lung, K Rick ^a   Gorko, Mary A ^a   Llewelyn, Jennifer ^a   Wiggins, Norman ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYSIS OF VARIANCE; ANALYTIC METHOD; ASSAY; AUTOMATION; BIOEQUIVALENCE; COMPLIANCE (PHYSICAL); CONFERENCE PAPER; CONFIDENCE INTERVAL; DRUG DETERMINATION; DRUG DOSAGE FORM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; PRIORITY JOURNAL; SPECTROPHOTOMETER; STATISTICAL ANALYSIS; STUDENT T TEST; TABLET FORMULATION; VALIDATION PROCESS;

EID: 3843068651     PISSN: 14639246     EISSN: None     Source Type: Journal    
DOI: 10.1080/14639240410001703465     Document Type: Conference Paper

References (8)

1. ICH QUALITY GUIDELINES Q2A & Q2B, Validation of analytical procedures, in International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.
2. FDA GUIDANCE DOCUMENT, Analytical Procedures and Methods Validation (Draft) (available at: http://www.fda.gov/cder).
3. PHARMACEUTICAL ANALYTICAL SCIENCES GROUP (PASG), UK, Guidance on the Development and Validation of Automated Methods for Finished Product Testing, vol. 1 (19 July 1999) (available at: http://www.pasg.org.uk).
4. MILLER, J. C. and MILLER, J. N., Statistics for Analytical Chemistry, 3rd edn (New York: Ellis Horwood PTR/Prentice Hall, 1993), p. 55.
5. PHARMACOPEIAL FORUM, 27 (2001), 3086.
6. PHARMACOPEIAL FORUM, 29 (2003), 194.
7. WESTLAKE, W. J., Biometrics, 32 (1976), 741.
8. CHOW, S.-C. and LIU, J.-P., Design and Analysis of Bioavailability and Bioequivalence Studies (New York: Marcel Dekker, 1992), p. 77.