Biopharmaceutics is an integral component of the overall development cycle of a drug. Evaluation begins during the drug discovery process, proceeds through compound selection, preclinical efficacy and safety testing, formulation development, clinical efficacy studies, and postapproval stages. At each stage, biopharmaceuti-cal scientists interface with colleagues in multiple disciplines including discovery chemistry and biology, drug safety assessment, clinical development, pharmaceutical development, regulatory affairs, marketing, and manufacturing. The ensuing section will discuss the general activities and impact at each stage of development and provide an overall view of the role of biopharmaceutics at various stages of drug development.
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