BIO375H5 Lecture Notes - Lecture 3: Patent Office, Patent Infringement, Cardiovascular Disease

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24 May 2017
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Presentation: after he posts the presentation on black board only then can you choose the order. The order of the choice is dependent on the date and time of the email. There are three big areas (order is from left to right): Discovery and pre - clinical (target biology lead drug candidate): Pre - clinical validation, toxicology. (this area is majorly composed of how you do the preclinical and produce something and to get ready for the next phase) Phase 4 why is this not visible: this is placed after the fda approval. Manufacturing, regulatory phase iv study (this is after fda approval) This segment can also be a part of the other three phases in clinical trials. The backwards arrows in the book is for you to plan ahead for marketing and the manufacturing. You should start to think about marketing toward the relative early stage of the product development procedure (not at the end of the cycle)