Transcript new drug application - Weatherford High School

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)
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.
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