Pharmaceutical Sciences and Drug Metabolism
The goal of Pharmaceutical Sciences and Drug Metabolism is to deliver a product that fits the needs of the patient. In Pharmaceutical Sciences, this work starts with a new drug molecule or protein from Discovery, making it in large scale to enable development and commercialization to begin. The active ingredient is formulated into tablets, capsules and other dosage forms to make available to the patient. Manufacturing processes and analytical methods are developed to make sure the products are consistent, safe and of high quality. These procedures are used for clinical supply preparation to enable the conduct of clinical regulatory studies. These processes are ultimately transferred to manufacturing to support the launch and production of the new product. Drug Metabolism similarly begins by characterizing the way the drug is absorbed, broken down and eliminated from the body. This is especially important during toxicology and clinical trials, where drug levels are monitored to ensure the safety of the patient. Development concludes with a regulatory dossier describing the preparation and quality of the new product, as well as the fate of the drug in the body.