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Quality by Design: Next Steps to Realize Opportunities? - page 22 / 37

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In Vivo BE* for Justifying Changes During Development

Capsule

Tablet

(WG)

Film

Coat

Site

Change

Change

in Drug

Manuf.

Solvent

-Coat

Site

Change

Tablet

(DC)

Multi-

Strength

Scale-up

Multi-

Strength

BE Study

Failed BE

To-Be-Marketed

Approval

*Generally 3-6 clinical bioequivalence tests are conducted in a NDA

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