Article (Scientific journals)
Advances in validation, risk and uncertainty assessment of bioanalytical methods
Rozet, Eric; Marini Djang'Eing'A, Roland; Ziemons, Eric et al.
2011In Journal of Pharmaceutical and Biomedical Analysis, 55, p. 848-858
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Keywords :
Bioanalytical method validation; results accuracy; standard curve; incurred sample reproducibility; measurement uncertainty
Abstract :
[en] Bioanalytical method validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application in order to trust the critical decisions that will be made with them. Even if several guidelines exist to help perform bioanalytical method validations, there is still the need to clarify the meaning and interpretation of bioanalytical method validation criteria and methodology. Yet, different interpretations can be made of the validation guidelines as well as for the definitions of the validation criteria. This will lead to diverse experimental designs implemented to try fulfilling these criteria. Finally, different decision methodologies can also be interpreted from these guidelines. Therefore, the risk that a validated bioanalytical method may be unfit for its future purpose will depend on analysts personal interpretation of these guidelines. The objective of this review is thus to discuss and highlight several essential aspects of methods validation, not only restricted to chromatographic ones but also to ligand binding assays owing to their increasing role in biopharmaceutical industries. The points that will be reviewed are the common validation criteria, which are selectivity, standard curve, trueness, precision, accuracy, limits of quantification and range, dilutional integrity and analyte stability. Definitions, methodology, experimental design and decision criteria are reviewed. Two other points closely connected to method validation are also examined: incurred sample reproducibility testing and measurement uncertainty as they are highly linked to bioanalytical results reliability. Their additional implementation is foreseen to strongly reduce the risk of having validated a bioanalytical method unfit for its purpose.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Boulanger, Bruno
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Advances in validation, risk and uncertainty assessment of bioanalytical methods
Publication date :
2011
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
55
Pages :
848-858
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 11 January 2011

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