lecture 8 Flashcards
what are the steps of the drug development process?
in vitro studies for lead compound, then animal testing for efficacy selectivity and mechanism, next clinical testing, then marketing
what are the three phases of clinical testing?
1= is it safe (pharmokinetics), 2= does it work,3 = does it work double blind?
time from synthesis to approval is roughly how many years?
10
what does IND do?
looks at composition, manufacturing, animal studies, clinical protocols, clinical investigators.
what much happen before allowing drug to go into clinical trials?
FDA approval
how many people used in phase 1?
20-80
how many of drugs are approved after phase 1?
20%
is phase 1 blinding or not?
not blinded
how many people in phase 2?
100-200
what percent of phase 2 are approved?
30%
is phase 2 blinded?
single blinded
which phase has placebo and active drug controls?
phase 2
how many people are in phase 3 ?
about 5000
which phase looks at side effects?
phase 3
what percent of phase 3 drugs are approved?
70%
NDA stands for what
new drug application
what is approved by FDA as part of NDA process?
the label
is the label a critical guide?
no
what is phase 4?
additional trials that FDA may request. post marketing surveillance. detection of low incidence side effects <1 in 10,000
what may result in black box warning or recall of drug
phase 4
_______ must be obtained for clinical trial, even of approved drug
IND
illegal to ship interstate for other than _______________.
label indication
generic manufacturer must prove what?
bioequivalence of generic formulation
demonstration of bioavailability is - or +_____ % of formulation?
20
more complex studies required for generic protein therapeutics calls what?
biosimilars
explain harrison narcotics acts of 1914?
regulation of production and use of narcotics. enforced by federal bureau of narcotics in treasury department, taxation of prescriber
controlled substances act of 1970 purpose?
decrease availability of drugs to abusers
controlled substances act of 1970 enforcers?
drug enforcement agency within department of justice, permits for dentists for fee
chemicals categorized into schedules based on what 3 things?
abuse potential, pattern and significance of abuse, risk of dependence
what is class 1 of controlled substances?
herion and marijuana
what is class 5 of controlled substances?
etc with some limits
what are class 3 and 4 of controlled substances?
limit to refills. 3=codeine. 4= BZD
what is class 2 of controlled substances?
morphine and hydrocodone. no prescription refills
