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MIDD has gained significant tractions in 505(b) (2) applications to guide formulation optimization and the selection of to-be-marketed formulation, by incorporating fit-for-purpose modeling and simulations, into the integration of the existing literature and the original sponsor data

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23 and our in-house cell-based assays showed the comparable activities of the alkaline-washed and conventionally purified antibodies (data not shown), indicating that the alkaline wash did not alter the activities of antibodies

Stem Cells Dev (2010) 19(12):188593