Résumé
In the past few years, the concept of Quality by Design has increasingly become an element in the development of analytical methods. After an assessment of the prior knowledge, it is possible to establish an analytical target profile that will serve as a basis for the risk assessment. Ultimately, this work can lead to a design space that gives the method a degree of flexibility that does not impact the method's performance. The great robustness provided by this approach challenges the existing regulatory approach.