Reference : Design Spaces for Analytical Methods
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/130125
Design Spaces for Analytical Methods
English
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Lebrun, Pierre mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Debrus, Benjamin mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, B mailto [> >]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2013
Trends in Analytical Chemistry [=TRAC]
Elsevier Science
42
157-167
Yes
International
0165-9936
London
United Kingdom
[en] Design Space ; Quality by Design ; Design of Experiments ; Robustness ; Optimization ; Probability Map ; Mean Response Surface
[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.
Researchers ; Professionals ; Students ; Others
http://hdl.handle.net/2268/130125

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