Process intelligent control design requirements

The program developed by LMI in response to these design requirements is called Process Intelligent Control (PICON). The individual design considerations are addressed in the following discussion. 

The API, as an outcome of the designed processes, needs to be fit for use in the formulating of the drug product where the requirements need to be well defined and understood. Increased API complexity, lower solubility and bioavailability, less stable APIs, and more complicated intelligent formulations as a result impose specific form requirements (salts, particles, etc.) calling for the process chemist s creativity and expertise to find adequate solutions. Polymorphism continues to be an important aspect to be managed, and there is an excellent chapter on crystallization and polymorph controls in this book. 

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