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Quality by Design: Next Steps to Realize Opportunities? - page 12 / 37

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BCS Applications

PRE-CLINICAL

PHASE I

PHASE II

PHASE III

CLINICAL-TRIAL-

FORMULATION

MARKETED

FORMULATION

POST-APPROVAL

CHANGES

MULTI-SOURCE

PRODUCTS

POST-APPROVAL

CHANGES

INITIAL CLASSIFICATION

CLASS CONFIRMED

PRODUCT CONFORMS TO

BCS SPECIFICATION

EQUIVALENCE IN VITRO

EQUIVALENCE IN VITRO - LEVEL 3

EQUIVALENCE IN VITRO

EQUIVALENCE IN VITRO - LEVEL 3

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