Atherton, John H. (2011) Physicochemical Data Requirements for the Design of Fine Chemicals Processes: Acquisition and Application. In: Pharmaceutical Process Development. Current Chemical and Engineering Challenges. RSC Drug Discovery Series (9). RSC, Cambridge UK, pp. 178-206. ISBN 978-1-84973-146-1

Design of a good manufacturing process requires much more understanding and information than is provided in a typical laboratory process description. This chapter outlines the scope of the data requirements and the understanding of the science required to support adequate design of optimised laboratory and manufacturing processes. The amount and nature of the information required depends strongly on the complexity of the process, and an approach to identifying critical data is described. Numerous examples are provided of the application of the acquired data to the optimisation of laboratory processes and to scale up.

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