Pre-study analytical method validation: Comparison of four alternative approaches based on quality-level estimation and tolerance intervals

Quality and Reliability Engineering International

Volumn 24, Issue 6, 2008, Pages 667-680

  Govaerts, Bernadette ^a   Dewé, Walthère ^b   Maumy, Myriam ^c   Boulanger, Bruno ^d  

^a UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^b GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^c UNIVERSITÉ DE STRASBOURG   (France)

^d UCB PHARMA   (Belgium)

Author keywords

; expectation tolerance interval; Analytical method validation; Content tolerance interval; Quality level; Variance components models

Indexed keywords

BLOCK CODES; CUSTOMER SATISFACTION; HIGH PRESSURE LIQUID CHROMATOGRAPHY; MAXIMUM LIKELIHOOD; MAXIMUM LIKELIHOOD ESTIMATION; NETWORK PROTOCOLS; QUALITY ASSURANCE; QUALITY FUNCTION DEPLOYMENT; RISK ASSESSMENT; SENSOR NETWORKS; STATISTICS; TOTAL QUALITY MANAGEMENT;

ACCEPTANCE LEVELS; ACCEPTANCE LIMITS; ALTERNATIVE APPROACHES; ANALYTICAL METHOD VALIDATION; ANALYTICAL METHOD VALIDATIONS; ANALYTICAL METHODS; ANALYTICAL PROCESSES; ANALYTICAL RESULTS; BIOANALYTICAL; CONFIDENCE BOUNDS; CONTENT TOLERANCE INTERVAL; DELTA METHODS; ESTIMATED PROBABILITIES; HPLC-UV; LOWER CONFIDENCE BOUNDS; MAXIMUM LIKELIHOOD APPROACHES; MEASUREMENT METHODS; QUALITY CHARACTERISTICS; QUALITY LEVEL; QUALITY LEVELS; TOLERANCE INTERVALS; VARIANCE-COMPONENTS MODELS;

QUALITY CONTROL;

EID: 54949099607     PISSN: 07488017     EISSN: 10991638     Source Type: Journal    
DOI: 10.1002/qre.943     Document Type: Conference Paper

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