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...
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First development phase: identification of the product's target quality profile and its critical attributes
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