Temple University 3 credits QARA
Preformulation research of small molecules is the foundation of pharmaceutical manufacturing. Inadequate understanding of the physical/chemical and biophysical properties of drug substance or excipient can lead to the development of formulations and manufacturing processes that are not robust. The ability of a company to demonstrate to health agencies a firm understanding of the "manufacturing science" related to the production of each dosage form is essential. This course describes the evolution of preformulation from a science dedicated to primarily characterizing basic drug substance and excipient attributes as they relate to the finished product to the science of understanding, utilizing and controlling such properties to optimize the manufacture and bioavailability of a dosage form. The influence of preformulation data in the era of Quality by Design (QbD) and expectations for outstanding science from global health authorities will be incorporated throughout the course.
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