PCL102H1 Lecture Notes - Lecture 1: Meningococcal Disease, Biopharmaceutical, Drug Discovery
26 Feb 2020
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Pcl102 lecture 1 (syllabus and intro: us fda approved 48 new drugs in 2019. Phase 1 clinical trail - initial safety testing in a small group of healthy volunteers. Phase 2 - assess safety and ef cacy in a small group of patients phase 3 - demonstrate safety and ef cacy in a large group of patients. Biopharmaceutical research and development process basic research - drug discovery - pre-clinical - phase 1,2,3 clinical trials - fda review - post approval research and monitoring. Basic research: scientists in biopharmaceutical research companies, government, academia and for- pro t research institutions contribute to understanding of the disease and potential drug targets. Drug discovery:researchers create a new molecule or select an existing molecule as the starting point, then perform tests on that molecule and optimize it to maximize its effect. They then move forward with one or more drug candidates.
