BIO375H5 Lecture Notes - Lecture 4: Genetically Modified Organism, Lipoprotein, Sample Size Determination

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24 May 2017
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Put emphasis on the clinical pathway (phase 1, phase 2, phase 3 and phase 4) Fda will require statistical data in the specific phase (which one?) Phase 4 is diff than the other phases but before that you need to look at certain things you need to consider. Regulatory pathway: only the path you want to submit the data following the fda procedure. What we talk about the week after next week. Need to do market research to collect some data to see when it is possible for the product can be competitive in the market (cake story) Refer to book if need be, not mandatory. The next ex is for diagnostics and devices. Yes for example it can treat both cardio disease and alzheimer"s. The 1st indication is cardio and the second is alzheimer"s. / but you"re using the same drug (a). But there have to be two different applications, do different fda applications for approval.