Benefit design challenges

In this chapter, the evolution of the active pharmaceutical ingredient (API) manufacturing process for sunitinib malate will be described. The different routes evaluated to prepare the API, the factors that influenced the choice of the commercial process, salt selection, scale-up experience, and regulatory issues will be discussed in detail. The benefits and challenges of developing a one-pot process will also be highlighted. It is hoped that this chapter will provide a sense of the spectrum of issues to be considered while designing a commercial process. 

Appreciate the benefits and challenges with design-implement experiences. 

While both liquid- and air-based thermal management systems operate under the same principle, each has different sets of benefits and challenges ranging from performance to cost and complexity of the overall HESS. Both systems include similar system design techniques. 

This chapter will focus on multi-dimensional NMR experiments that have been designed with multiple receivers in mind. We shall discuss the benefits and challenges of such experiments, their applications in NMR of both small organic molecules and bio-molecules (proteins). 

The second challenge is to relate the desired product attributes to the material properties of the ingredients and the structure of the product. For example, the development process would have been much more efficient if a model was available to describe the behavior of cleansing bars and structured food products. Without the benefits of predictive models, as is the present status for many consumer products, extensive trial-and-error by experiments are required. Even if a comprehensive model based on first principles is not available, a combination of physical insights and heuristics can still help improve the development process. Chapters 1-2 report some new developments in this area. See also [11] for a more detailed discussion on the issues and needs related to the roles and uses of property models in product design. 

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