Article (Scientific journals)
Validation of analytical methods involved in dissolution assays: Acceptance limits and decision methodologies
Rozet, Eric; Ziemons, Eric; Marini Djang'Eing'A, Roland et al.
2012In Analytica Chimica Acta, 751, p. 44-51
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Keywords :
Quality by design; tolerance interval; method validation; analytical target profile; acceptance limits; dissolution methods
Abstract :
[en] Dissolution tests are key elements to ensure continuing product quality and performance. The ultimate goal of these tests is to assure consistent product quality within a defined set of specification criteria. Validation of an analytical method aimed at assessing the dissolution profile of products or at verifying pharmacopoeias compliance should demonstrate that this analytical method is able to correctly declare two dissolution profiles as similar or drug products as compliant with respect to their specifications. It is essential to ensure that these analytical methods are fit for their purpose. Method validation is aimed at providing this guarantee. However, even in the ICHQ2 guideline there is no information explaining how to decide whether the method under validation is valid for its final purpose or not. Are the entire validation criterion needed to ensure that a Quality Control (QC) analytical method for dissolution test is valid? What acceptance limits should be set on these criteria? How to decide about method’s validity? These are the questions that this work aims at answering. Focus is made to comply with the current implementation of the Quality by Design (QbD) principles in the pharmaceutical industry in order to allow to correctly defining the Analytical Target Profile (ATP) of analytical methods involved in dissolution tests. Analytical method validation is then the natural demonstration that the developed methods are fit for their intended purpose and is not any more the inconsiderate checklist validation approach still generally performed to complete the filing required to obtain product marketing authorization.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric  ;  Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Marini Djang'Eing'A, Roland ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Boulanger, Bruno
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Validation of analytical methods involved in dissolution assays: Acceptance limits and decision methodologies
Publication date :
2012
Journal title :
Analytica Chimica Acta
ISSN :
0003-2670
eISSN :
1873-4324
Publisher :
Elsevier, Amsterdam, Netherlands
Volume :
751
Pages :
44-51
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 16 October 2012

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