Week 1 Flashcards
who is the biggest employers of organic chemists
drug manufactures
how is the first round of testing done for antibiotics
in vitro
how many samples can big pharma companies test through high throughoutput systems
100,000 samples per day
How can antibiotics be tested in rapid form. What is this test called
high throughput screening tests
Once a drug shows promise throw in vitro what is the drug tested for_____ and what is the test called (2 names)
carcinogenicity
bacterial mutation or Ames test
how many phase’s are there of drug testing before it hits the market?
4 phases
what type of people are tested in phase 1 and what are the researchers looking for?
How long does phase one go for?
Tested on healthily people
looking for toxicity effects and metabolism.
Only last for days or a few week
Phase II is looking for, how many people, how, and how is it performed.
Double blind study and a placebo pill is used.
Smaller amount of patients than phase III
Drug dosages and adverse effects
Phase III looks for what and how many people are in it and how is it performed?
Looks for less common adverse side effects
A lot more people and Double blind study and a placebo pill is used.
What is the estimated cost to bringing a new drug on the market
802 million
What is considered a blockbuster drug
profits with over 1 billion dollars per year
Where are many of the drug trails being outsourced to? (country)
ASIA
What does PDUFA and what was the purpose
Prescription Drug User Fee Act passed 1992 allowed the FDA to hire additional evaluators due to the 1 million dollar fee
What is Phase IV intended for
If the FDA thinks there is safety questions about the drug and they could require additional follow up monitoring.
Drug companies spent around ______ per US physician in 2001
$13,000
How can drug companies extend their patent of 20 (2 ways)
if they do testing in children
suing companies that are trying to sell a generic
____ in 100,000 potential drugs makes it to the market
1
how many % of drugs pay for their development cost
30%
How much did omeperazole(prilosec) make in a year and is it a blockbuster drug
6 billion a year and yes it is
_____ was originally marketed as _____ but its side effect was growth of hair
Rogaine
antihypertensive
___1__ was meant for ___2_ and __3___ but gave a woody
1-Viagra
2-angia
3-antihypertensive
an unexpected reaction is known as (x2)
idiosyncratic
paradoxical
____ was originally approved for reducing hot flashes but was widely used to keep post-menopausal women feeling feminine and to reduce osteoporosis
Premarin
______ was originally tested and marketed for epileptic seizures but off label use for neurological pain, schizophrenia, bipolar disorder. What % of this was prescribed for off label. They were fined how much for this the first time and how much the second time
Gabapentin (Neurontin)
80%
430 million
2.3million for lyrica (used for anti-seizure for fibromyalgia)
Molecules which increase risk of birth defects are called______
teratogens
What are the 5 classes for pregnant women
A,B,C,D and X
Category A
name 1 drug in this category!
Well controlled testing. no risk
levothyroxine
Category B
1 drug
Insufficient data or little data but safe
amoxicillin