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Pharmaceutical process development model-based optimization

The goal of this chapter is to provide a brief overview of standard engineering methods for process development and scale-up and discuss their applicability to the pharmaceutical industry. Model-based design methods and their impact on optimization, scale-up, and process control are discussed. The state of the art is contrasted to a realistic desirable state where these methods become part of a new standard of technological articulation. [Pg.57]

The chapter is organized as follows. First, to establish a common language, we define some common terms from both a pharmaceutical and an engineering perspective. Subsequently, we review model-based design and optimization as a framework for product and process development and optimization, process scale-up, and continuous improvement activities. The role of process and analytical technology (PAT) methods and principles in this framework is discussed. Finally, the main areas requiring effort are identified. [Pg.62]


See other pages where Pharmaceutical process development model-based optimization is mentioned: [Pg.83]    [Pg.64]    [Pg.396]    [Pg.858]    [Pg.5]    [Pg.423]    [Pg.22]    [Pg.95]    [Pg.470]    [Pg.579]    [Pg.266]    [Pg.85]    [Pg.178]    [Pg.734]    [Pg.7]    [Pg.52]    [Pg.353]    [Pg.2036]    [Pg.236]    [Pg.1009]    [Pg.98]    [Pg.52]    [Pg.156]    [Pg.73]    [Pg.499]   
See also in sourсe #XX -- [ Pg.62 , Pg.63 , Pg.64 ]




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Base Model Development

Based Optimization

Developability optimization

Model developed

Model development process

Model-Based Process Development

Optimal process development

Optimism model

Optimization model-based

Optimization models

Pharmaceutical process

Pharmaceutical process development

Pharmaceutical processing

Process optimization model

Process pharmaceutical processes

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