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1. Development prerequisites
In this example, we wish to develop an immediate-release tablet dosage form containing a class 2 active substance (AS) according to the Biopharmaceutical Classification System (BCS) . To facilitate discussion of this example, we have chosen a non-steroidal anti-inflammatory drug (NSAID) as the active substance. The proposed approach is inspired by the example proposed by the Food and Drug Administration (FDA) on the Quality by Design (QbD) approach applied to generic drugs
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Development prerequisites
First development phase: identification of the product's target quality profile and its critical attributes
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