Intro to pharmacology Flashcards
the two major areas of study of pharmacology
pharmacokinetics (PK)
pharmacodynamics
what is pharmacokinetics (PK)?
what the body does to the drug
what is pharmacodynamics?
what the drug does to the body
what are the 4 things they look at with pharmacodynamics?
(ADME)
Absorption
Distribution
Metabolism
Elimination
what are “me too” drugs?
the drug’s mechanism of action mimics a drug that already exists
what is “son of a drug”?
when you slightly modify an existing drug + re-patent it as a new drug
what is “repurposing” a drug?
finding something new that the drug can treat that it wasn’t intended for
phases of drug testing
preclinical testing
phase 0
phase I
phase II
phase III
To Market
Drug Approval
phase IV
preclinical testing
-location in drug testing order
-duration
-what occurs
1st
3-6 years
create “proof of concept” in a lab
phase 0
-location in drug testing order
-duration
-what occurs
2nd
several months
micro-dose 10-15 humans
no efficacy/safety data
no benefit for subject
phase I
-location in drug testing order
-duration
-what occurs
3rd
~1 year
test 20-80 disease-free humans
gets safety data
no efficacy data
phase II
-location in drug testing order
-duration
-what occurs
4th
1-2 years
test 200-300 humans with disease
efficacy + safety data (+ dose range, side effects)
phase III
-location in drug testing order
-duration
-what occurs
5th
3-5 years
test thousands of humans
efficacy + safety data
*highest rate of failure
To Market
-location in drug testing order
-duration
-what occurs
6th
1-2 years for FDA review
file NDA (new drug application) with FDA
Drug Approval
-location in drug testing order
-what occurs
7th
FDA approves for only a specific use
what is “off-label” use of a drug?
when a drug is used to treat a disease it is not approved for
what % of drugs enter clinical testing? what % of those are approved?
0.1% drugs enter clinical testing
<12% of those are approved
phase IV
-location in drug testing order
-what occurs
last (8th)
repurposing of the drug occurs
continued surveillance of how drug behaves
overall duration and cost of drug testing
10+ years
$2.6 billion per 1 new drug
duration of a drug patent
20 years
what is a black box warning?
says a drug should be used with caution
does NOT mean drug shouldn’t be used
what happens after a patent expires?
any company can sell the drug using generic name
4 names a drug can have (in order)
chemical name (5-methyl-10,11-dihydro)
company code name (MK801)
generic name (dizolcipine)
brand name (Strokestop)
who gives the generic name to a drug and when?
USAN gives name during clinical testing
