1. new drug application(NDA) ‘I want a new drug’--huey Lewis ok huey….about $800 million and 10 years. 1 in 5 new drugs get through NDA FDA wants…. development stage----laboratory work(structure, doseage) then animal testing results, other countries, then approval for clinical trials new drug application----must be approved by committees in medical, microbiology, pharmacology, chemistry, statistical phase 1---a few healthy volunteers to get max tolerated dose and get pharmacokinetics(ADME)

2. new drug application phase II----find optimmal dose, more data.hundreds of volunteers with target disease. if effective keep going to….. phase III----several thousand volunteers(hosp), double blind, placebo or vs known competitor NDA is turned into FDA for approval if approved drug goes on sale so now… phase IV---adverse drug problems are reported to FDA medwatch. maybe drug gets pulled off. IND review---investigational new drug. permit for interstate shipment of nonapproved drugs.

3. patent period/generic drugs expires 20 years after application. others can make the product after 20 years but must show equivalence and must use a new name. many disciplines are needed to bring a new drug---toxicologist, pharmacist,pharmacologist, doctor,ect pharm co will hire schools and institutes to do research why???---find new ingredient or modify active ingredient