BIO SCI N150 Lecture 4: 4
21 Dec 2016
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Need to large reserach studies of efficacy befor edurg is approved. Young healthy volunteers, not patients to understand pharmacodynamics- how long does drug stay in system. Start low and go slow- give small dose to human being. (first humans to take drugs)- are there any adverse effects. Give it to 2nd person and if safe and then to 3rd. Increase dose and get a cohort of three people. Keep increasing dose until adverse effect comes to know maximally tolerated dose. 2b - demonstrate safety and collect data for phase 3 studies. Test efficacy of new drug- most critica; for fdaapproval. Around 90% of drugs that make it to clnical studies will fail. Company will want to fail as early as possible to save money. The clinical trials cost 335 million but the helath benefit due to the minority successful ones was 18. 1 billion.
