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Quality by Design: Next Steps to Realize Opportunities? - page 8 / 37

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Example Attribute: Bioavailability

Objective: Maximize & reproducible

Absorption mechanism (passive, active, site specific)

Physico-chemical attributes (solubility, dissolution rate, salt selection, particle size, morphic form, stability of drug substance ….)

Formulation design (disintegrating agent, wetting agent, solubilizer, pH modifiers, absorption enhancers,..)

Process design (wet/dry granulation, lubrication, compaction,….)

Specifications and controls on all critical variables

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