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    Live From Shows

    Pharmaceutical Excipients—Biopharmaceutical, QC and Regulatory Considerations

    ...

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    11.07.17
    An unending list of diverse and versatile excipients is available to pharmaceutical scientists who are involved with dosage form design and drug product development. These excipients are either small molecules or macromolecules, and in order to be qualified for use in drug products, at least in the U.S., they must meet the United States Pharmacopeia-National Formulary (USP-NF) compendial status. In recent years, we have seen an evolution in the use of excipients in drug products that go well beyond their traditional use as formulation and manufacturing aids to include excipient effects on biological barriers such as mucosal membranes and metabolic enzymes. New uses of an excipient permitted for use in a regulated drug product in the U.S. or the development of novel excipients are driven by scientific and business decisions to address unmet medical needs, including the essential need for excipients in drug products, patent protection, and revenues. This short course’s objective is for expert faculty from the pharmaceutical industry, USP, and Food and Drug Association to address the aforementioned areas and guide pharmaceutical scientists in their dosage form design and drug product optimization efforts.

     8:30 a.m. – 4:00 p.m., Nov 12, Room 23AB
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