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Quality by Design: Next Steps to Realize Opportunities? - page 10 / 37

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Formulation & Process Design

Starting at small scale – pilot – clinical/prod.

Need tools to screen/evaluate various design prototypes

In Vitro Dissolution Test

bio-studies to ensure relevance of in vitro dissolution test

Relevance based on physico-chemical aspects of the drug and formulation

Observations (personal)

Often a dissolution test is used to screen/evaluate experimental formulations without sufficient considerations or verification of  its in vivo predictability (relevance)

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