BIO375H5 Study Guide - Midterm Guide: Medical Device, Risk Assessment, Mass Production
Document Summary
Key concepts of new product development needs to consider: Nda: reimbursement, have to look at what customers want, so must find a way to know, after clinical testing, move on the clinical test 1 on human beings. But: manufacturing, scale up, mass production, you need to make fda happy because they will check manufacturing, ind investigational new drug (before phase 1, nda new drug application (after phase 3) (surveys). How to make a new product development (cid:498)less risky(cid:499: toxicity, absorption and excretion in the body, risk assessment. If our product is a medical device: efficacy, toxicity. If the drug development process if struggling, should we keep going or abandon it right away: early failure vs late failure, generally, early failure is better than late failure. How do we know when we should abandon our drug development: regulatory pressure, market pressure, market is too competitive regardless of if your product is successful, so you must abandon.
