A Framework for Efficient Process Development Using Optimal Experimental Designs

作者：van de Ven Peter; Bijlsma Sabina; Gout Erik; Maarschalk Kees van der Voort; Thissen Uwe^*

来源：Journal of Pharmaceutical Innovation, 2011, 6(1): 24-31.

DOI：10.1007/s12247-011-9098-2

• Design of experiments (DOE)
• Optimal design
• I optimal
• Quality by design
• Process development

Introduction The aim of this study was to develop and demonstrate a framework assuring efficient process development using fewer experiments than standard experimental designs.
Methods A novel optimality criterion for experimental designs (Iw criterion) is defined that leads to more efficient process development because: (a) prior knowledge is used in the experimental design to focus on optimal processing conditions and (b) a lean design is used which can dramatically reduce the number of experiments compared to standard designs. In this way, the criterion serves as a framework to connect a series of screening and optimization designs.
Results The philosophy behind the Iw criterion is explained including a detailed step-wise discussion how to apply it in practice. Moreover, its advantages were shown in an industrial process development case using a screening and an optimization design that were not explicitly connected. In this paper, a reduction of 21% of experiments could be obtained compared to the traditional approach using standard experimental designs and no framework.
Conclusions The Iw criterion is a valuable tool to increase accuracy and to speed up research that contain sets of experiments and where prior knowledge is already available or will be derived using screening designs.

• 出版日期2011-4