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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Development prerequisites

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page Quality risk management applied to pharmaceutical product development

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

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Bibliography

(1) - AMIDON (G.L.), LENNERN (H.), SHAH (V.P.) et al - A theoretical basis for a biopharmaceutic drug classification : the correlation of in vitro drug product dissolution and in vivo bioavailability. - Pharm Res., 12, p. 413-420 (1995).
(2) - -...

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