MIMM 387 Lecture : Jan 27 2012- murgita.docx

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Company pursuing a monoclonal ab that bound to the surface of t cells (thus inactivating them). Biotech companies want to make money as well; they moved from the positive preclinical studies to clinical studies quickly. Phase i studies were done (testing safety in drugs). Companies want to do this fast because they have a limited patent life on the drug. So the first human trials were in 2006. In order to do so, they often involve normal healthy volunteers, who often volunteer for the money. So in the uk, they recruited a group of men and offered them money. The phase i study was designed with a large margin of safety; they showed a certain dose was not dangerous in non-human primates. Phase i designs are dose escalation experiments (you gradually increase the dose until you see toxicity); so you start at a dose you know is safe.

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