Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).

Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effectiv...

Combined application of computational fluid dynamics (CFD) and design of experiments (DOE) to hydrodynamic simulation of a coal classifier

Combining the computational fluid dynamics (CFD) and the design of experiments (DOE) methods, as a mixed approach in modeling was proposed so that to simultaneously benefit from the advantages of both modeling methods. The presented method was validated using a coal hydraulic classifier in an industrial scale. Effects of operating parameters including feed flow rate, solid content and baffle le...

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT).

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD) princi...

Chapter 18 Process Analytical Technology ( PAT ) and Quality by Design ( QbD ) Multi - and Megavariate Data Analysis

Manufacturing industries need Design of Experiments (DoE)

Although experimentation is a frequent activity of engineers, they usually use primitive strategies to carry on their experiments. A survey identifies the needs of using an efficient and practical technique for the experimentation. Although Six Sigma improvement initiative emphasized the use of Design of Experiments (DoE) for experimentation, engineers still consider it a difficult technique to...