HLTH 353 Lecture Notes - Lecture 4: Harrison Narcotics Tax Act, Prescription Drug User Fee Act, Postmarketing Surveillance
1 Oct 2018
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Drugs & society - hlth 353 - exam 1 notes. Step 1 = preclinical research and development. A chemical must be identified as having potential value in the treatment of a particular condition. Run a series of tests on at least two or more animal species. Records must be kept of side effects, absorption, distribution, metabolism, excretion and dosages of the drug necessary to produce the various effects. An average of 1 in 1000 tested compounds pass these preclinical trials and are proposed for clinical studies. Step 2 = clinical research and development (human testing) Phase 2 = clinical pharmacological evaluation stage. Because the safety of the new drug has not been thoroughly established, a few patients (100-300) with the medical problem the drug is intended to treat participate in these studies. Phase 3 = extended clinical evaluation stage. When medically appropriate, the drug is given to thousands of volunteer patients.
