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Under the Quality by Deign (QbD) paradigm, new pharma product must be correctly designed to take into account the disease and its impact on the patient; the patient population; the drug properties; the preferred route of administration (from a clinical and a marketing perspective); and the requirements of the organization manufacturing the product.  The preferred dosage form will usually be an oral solid dosage form (OSD), usually a tablet, which are relatively cheap to manufacture and administer, and can be produced with a wide range of release profiles.

Drug substance properties must be taken into account when developing the product formulation and manufacturing process. Selection of a sub-optimal process or formula may result in considerable extra costs and delays, and even failure.

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