PCL102H1 Lecture Notes - Lecture 3: Teratology, Visible Human Project, Pharmacodynamics
14 Sep 2016
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Pcl102h1 spring 2013 the art of drug discovery. Lecture 16: clinical trials and the food and drug administration (f. d. a. ) Obstacles of change agents of change. Non-teratogenic in mice, but teratogenic in primates. Frances kelley (canadian working in fda) refused to approve thalidomide in usa tighter safety amendments; proof of efficacy now required today, this drug is used for leprosy and aids. 1980s: first years of hiv, no drugs to treat it. Act up (aids coalition to unleash power) closes fda. Activists, protests, international press coverage, among them vito russo. 8 days later, new regulations were made. Screen multiple drugs from multiple companies (up to 12 drugs) Master umbrella investigational new drug (ind) approval from fda. Neoadjuvant treatment: giving chemotherapy treatment before surgery. Adaptive randomization: use early data from one set of patients to guide decisions about investigational drug: a drug not yet approved by the fda which treatments might be more useful for patients later in the trial.
