Reference : Critical Review of Near-Infrared Spectroscopic Methods Validations in Pharmaceutical App...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/111263
Critical Review of Near-Infrared Spectroscopic Methods Validations in Pharmaceutical Applications
English
De Bleye, Charlotte mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Chavez, Pierre-François mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Mantanus, Jérôme mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Marini Djang'Eing'A, Roland mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > Département de pharmacie > Département de pharmacie >]
2012
Journal of Pharmaceutical & Biomedical Analysis
Elsevier Science
69
125-132
Yes (verified by ORBi)
International
0731-7085
1873-264X
Oxford
United Kingdom
[en] Near-infrared spectroscopy ; Method Validation ; Results Accuracy ; Process Analytical Technology ; Review
[en] Based on the large number of publications reported over the past five years, near-infrared spectroscopy (NIRS) is more and more considered an attractive and promising analytical tool regarding Process Analytical Technology and Green Chemistry. From the reviewed literature, few of these publications present a thoroughly validated NIRS method even if some guidelines have been published by different groups and regulatory authorities. However, as any analytical method, the validation of NIRS method is a mandatory step at the end of the development in order to give enough guarantees that each of the future results during routine use will be close enough to the true value. Besides the introduction of PAT concepts in the revised document of the European Pharmacopoeia (2.2.40) dealing with near-infrared spectroscopy recently published in Pharmeuropa, it agrees very well with this mandatory step. Indeed, the latter suggests to use similar analytical performance characteristics than those required for any analytical procedure based on acceptance criteria consistent with the intended use of the method.
In this context, this review gives a comprehensive and critical overview of the methodologies applied to assess the validity of quantitative NIRS methods used in pharmaceutical applications.
CIRM
Région wallonne : Direction générale des Technologies, de la Recherche et de l'Energie - DGTRE ; Fonds de la Recherche Scientifique (Communauté française de Belgique) - F.R.S.-FNRS
Researchers ; Professionals
http://hdl.handle.net/2268/111263
10.1016/j.jpba.2012.02.003

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