BIO375H5 Lecture Notes - Lecture 4: Cardiovascular Disease, Sample Size Determination, Medical Device
Document Summary
Regulatory pathway: the path that you want the fda to approve (will talk about this in 2 weeks). Marketing: do research to see when it"s possible for your product to be compatible in the market. Common risk factors (wrt drugs: efficacy: related to how effective the drug is; indication use drug a to treat cardiovascular disease is an indication that the drug works. How quick can the drug perform the task for the indication in question: toxicity: if too high, risk is too high. Different drugs have different standards for toxicity levels: absorption and excretion in the body: aka adme properties. Different drugs may have different standards for these values. Specificity: ex; in a lab, if you"re using an anti-body. You need the right amount (ex; you could have a simple w very little amount and it could still work) To make sure that the science behind the test is correct.
