Quantifying uncertainty in determination of polysaccharides in glycoconjugate vaccines based on in-house validation data

Accreditation and Quality Assurance

Volumn 17, Issue 2, 2012, Pages 177-182

  Murtas, Susanna ^a   Gaggioli, Andrea ^a   von Hunolstein, Christina ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

Author keywords

Bias; Glycoconjugate vaccines; Precision; Quantifying uncertainty

Indexed keywords

EID: 84858800752     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00769-012-0876-4     Document Type: Article

References (12)

1. UNI CEI EN ISO/IEC 17025 (2005) General requirements for the competence of calibration and testing laboratories. International Organization for Standardization, Geneva.
2. EURACHEM/CITAC (2000) Quantifying uncertainty in analytical measurement. 2nd edn. EURACHEM.
3. OCABR OF HUMAN BIOLOGICALS 2010 guidelines book. European Directorate for the Quality of Medicines & HealthCare (EDQM), Strasbourg.
4. Ravenscroft N, Averani G, Bartoloni A, Berti S, Bigio M, Carinci V, Costantino P, D'Ascenzi S, Giannozzi A, Norelli F, Pennantini C, Proietti D, Ceccarini C, Cescutti P (1999) Size determination of bacterial capsular oligosaccharides used to prepare conjugate vaccines. Vaccine 17: 2802-2816.
5. EDQM-Quality Management Documents for the OMCL Network (2011). Uncertainty of Measurement-Part 1.
6. EURACHEM/CITAC Guide (2007) The use of uncertainty information in compliance assessment. EURACHEM.
7. Bardotti A, Averani G, Berti F, Berti S, Carinci V, D'Ascenzi S, Fabbri B, Giannini S, Giannozzi A, Magagnali C, Proietti D, Norelli F, Rappuoli R, Ricci S, Costantino P (2008) Physicochemical characterization of glycoconjugate vaccines for prevention of meningococcal diseases. Vaccine 26: 2284-2296.
8. ICH Topic Q2A guideline (1995) Validation of analytical methods: definitions and terminology. European medicines Agency (EMA), London.
9. ICH Topic Q2B guideline (1997) Validation of analytical methods: methodology. European medicines Agency (EMA), London.
10. Westgard QC (2011) http://www. westgard. com. Accessed 8 May 2011.
11. Barwick VJ, Ellison SLR (1999) Protocol for uncertainty evaluation from validation data. VAM Technical report No. LGC/VAM/1998/088.
12. Boris Iglewicz and David Hoaglin (1993), Volume 16: how to detect and handle outliers, The ASQC basic references in quality control: statistical techniques, Edward F. Mykytka, Ph. D., Editor.