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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