BIO375H5 Lecture Notes - Lecture 4: New Product Development, Statistical Significance, Medical Device
Document Summary
Have to create a good looking portfolio. When they keep doing this process they can increase the money that they invest for future research. Understand these 3 concepts: vertical model, horizontal model, hybrid model jumping from one stage to another, take money from horizontal model and invest back. Have to do a pre-clinical test, then clinical (phase 1, 2, 3), then application to go to market and then phase. New product development needs to consider these 4 concepts: regulatory pathway, contact the fda before you start. Using these 4 steps is known as the iterative pathway: a procedure in which repetition of a sequence of operations yields results successively closer to a desired result. After phase 3 clinical testing = nda (new drug application) Rick assessment: vertical model is much riskier than horizontal model. Ex: a product that is high in toxicity and low in absorption will be very risky, you can still invest in it though, but larger risk.
