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For over a decade the pharmaceutical industry has been in flux as a result of a range of pressures and a growing realisation that the traditional drug discovery and development model was not working well. This chapter examines some of the changes that the pharmaceutical industry has been subject to, and discusses how this changing environment has impacted the multi-disciplinary teams of chemists, chemical engineers and technologists working in the field of process research and development. In particular, the pressures to lower development costs and meet rising regulatory expectations are creating both challenges and opportunities for development scientists.

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