Design Spaces for Analytical Methods

Rozet, Eric; Lebrun, Pierre; Debrus, Benjamin; Boulanger, B; Hubert, Philippe

doi:10.1016/j.trac.2012.09.007

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Article (Scientific journals)

Design Spaces for Analytical Methods

Rozet, Eric; Lebrun, Pierre; Debrus, Benjamin et al.

2013 • In TrAC: Trends in Analytical Chemistry, 42, p. 157-167

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/130125

DOI
10.1016/j.trac.2012.09.007

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Keywords :

Design Space; Quality by Design; Design of Experiments; Robustness; Optimization; Probability Map; Mean Response Surface

Abstract :

[en] Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a Quality by Design (QbD) approach, there have been many discussions on the opportunity for analytical method developments to follow a similar approach. A key component of the QbD paradigm is the definition of the Design Space of analytical methods where assurance of quality is provided. Several Design Spaces for analytical methods have been published, stressing the importance of this concept. This paper aims at explaining what is an analytical method Design Space, why it is useful for the robust development and optimization of analytical methods and how to build such a Design Space. A strong emphasis is made by distinguishing the usual mean response surface approach, overlapping mean response surfaces and the desirability function one to other probabilistic approaches as only these last ones correctly define a Design Space. In addition, recent publications assessing the Design Space of analytical methods are reviewed and discussed.

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Lebrun, Pierre ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Debrus, Benjamin ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Boulanger, B

Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Language :

English

Title :

Design Spaces for Analytical Methods

Publication date :

2013

Journal title :

TrAC: Trends in Analytical Chemistry

ISSN :

0165-9936

eISSN :

1879-3142

Publisher :

Elsevier Science, London, United Kingdom

Volume :

Pages :

157-167

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 06 September 2012

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Scopus citations^®

213

Scopus citations^®
without self-citations

199

OpenCitations

165

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