BLG 699 Lecture Notes - New Product Development, Pharmacology, Atorvastatin
Document Summary
Phases of clinical trials or human testing. Stages of new product development: discovery research identification and pharmacological testing of the product, development research testing of product from animal (pre-clinical) through clinical (human) trials, registration and maintenance regulatory submissions review and post-approval activities. Discovery researchers may discover through requires researchers to identify a promising compound for development. New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. Tests of molecular compounds to find possible beneficial effects against any of a large number of diseases. New technologies such as those that provide new ways to target medical products to specific sites within the body or to manipulate genetic material. Need to find the right candidate" with vast criteria/properties. Once researchers identify a promising compound for development, they conduct experiments to gather information on: How it is absorbed, distributed, metabolized, and excreted. Its potential benefits and mechanisms of action.
