Module 3 2019

• Clinical formulation dry granules in capsules • Commercial formulation wet granulated in capsule • T max 6 hours, T ½ 14 – 16 hours • Proposed approach to Performance BA/BE Strategy • Understand the effect of storage on dissolution performance • Understand effect of DP release (In-vitro dissolution) on In-vivo performance • Leads to demonstration of satisfactory In-vivo performance of a wide range of dissolution profiles • These effects can be modelled using commercially available software • In the scenario above it was predicted that dissolution curves with 80% release in 6 hours would have no effect on BE Performance Testing: Scenario

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