L41 BIOL 2010 Chapter Notes - Chapter 9: European Medicines Agency, Therapeutic Index, Investigational New Drug
27 Sep 2017
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Federal food, drug, and cosmetic act in 1938. Required to test drug in at least two species of animals. Makes application to fda for investigational new drug status. Pharmacokinetics - what body does to drug. Pharmacodynamics - what drug does to body. Tests safety in small number of healthy volunteers. Single ascending doses - small group given single dose, dose increases if no side effect. Multiple ascending doses - small group given multiple small doses. Receive drug, placebo, or standard of care. Submit new drug application for small molecule drugs, biologic licensing application for biologics. Ten months to two years for fda to review data. Taking data from several clinical trials for same drug. Orphan drugs (patient population < 200,000 in us) - seven years. After exclusivity and patent protection ends for innovator drug. Formulation may be different, data required to prove equivalent bioavailability. Formulation - different chemical substances combined to make drug.
