Design Space

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Chapter: Pharmaceutical Engineering: Statistical Experimental Design

The distinction that can be made between a single response surface map and true process design space is that the latter is dynamic and begins when the drug is conceived and evolves over the entire life cycle of product.


DESIGN SPACE

The distinction that can be made between a single response surface map and true process design space is that the latter is dynamic and begins when the drug is conceived and evolves over the entire life cycle of product (Fig. 18.2) (Lepore and Spavins, 2008).

The foregoing discussion was intended to outline the philosophy behind statistical approaches to experimental design and their relevance to pharma-ceutical process optimization. The reader is referred to the texts cited and the broader foundational literature for thorough discussion of the mathematical


FIGURE 18.2 Design space development.

approach and examples of statistical designs. In addition, it should be noted that there are numerous computer software packages available that once familiar with the fundamentals can be employed to design and analyze experiments.

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