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        Drug Product Development

        Pre-formulation

        ?  Physicochemical properties: solubility, pKa, logP, hygroscopicity

        ?  Screening: polymorph, salt, cocrystal, amorphous dispersion

        ?  Solid state/solution stability: heat, humidity, light, pH, oxidation


        Formulation

        ?  Oral solid dosage form design, development

        ?  Drug/excipient compatibility, stability

        ?  Solubility, bioavailability enhancement

        ?  Controlled release dosage form design, patent strategy


        Process Development and Scale-up

        ?  Pharmaceutical manufacturing process

        ?  Development: wet/dry granulating, tableting, coating,

        ?  Beads drug layering/coating, lyophilization

        ?  Commercial size scale-up

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