BIO375H5 Lecture Notes - Lecture 3: Drug Development, Whatever Works, Surrogate Endpoint
Document Summary
The arrival of a new drug on the market has often taken 10 years for human testing, total development costs could exceed 1 billion. Old horrors of untested medicines pushed upon consumers do not happen again. Any new product that comes into the market should choose the best regulatory path. Unless you know regulatory path, you don"t know your cost that"s why it"s critical. Us refused to expose this product back then. Us fda website review variety of products so go into the website when you wanna know about the product. Specific doses the dose the drug is approved at. The drug is already in the market and we can"t change the dose anymore. Comparing 2 drugs is not based on the dose range that a scientists will do. They are compared based on specific doses that passed the regulatory. This is the difference between the experimental design and clinical trial.
