US Pharm Exam – Practice Questions & Answers |
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Terms in this set (190)
What are the 4 components to the 1. drug discover (5 years)
drug development process and how 2. Pre clinical (1.5 years)
long on average does each take? 3. clinical trials (6 years)
4. Drug approval (1-3 years)
how many compounds typically start start with around 5000 compounds in the discovery
the drug development process, how phase, drops to 250 in pre-clinical, 5 in clinical trials,
does this number change throughout? and 1 drug gets approved
How much does it cost on average to 1-2 billion dollars
bring a new drug into this world?
what is one of the most recent trends an increase in partnerships/collaborations between
in drug development? industries, "sharing development ideas" in order to
succeed together, otherwise buy out competition
How are drugs priced? whatever the market will permit, companies need to
make enough money off them to recover their initial
investment and have money left over to make new
drugs
What part of the drug development drug discovery, by screening compounds, currently
process would AI have the most 1000s of drugs are tested to find which would be
impact on? best to go into pre-clinical testing
What are the two concerns during safety of the drugs and pharmacokinetics (drug
pre-clinical phase? administration, dosage, half life, elimination)
,IND Apl (+when) investigational new drug application that happens
after the pre-clinical phase and before the clinical
phase
An FYI to the FDA of what you plan to do, explaining
your pre-clinical work and how it will advance into
clinical trial, FDA can give advice before you start
clinical trials however if you don't hear from them in
30 days you can proceed, but FDA can still give you
feedback after
phase 1 clinical trial Smaller population (20-100), usually younger healthy
individuals, still just testing safety and
pharmacokinetics to prove drug is doing what we
want it to in humans as it was in animals, still not
worried about efficacy
phase 2 clinical trials when efficacy/pharmacodynamics begins to be
tested (still concerned about safety and
pharmacokinetics too)
- involves 100-500 subjects, now including people
with disease the drug is for
phase 3 clinical trials - proof of concept- large randomized controlled
studies occur here
- studies use a placebo if there is not another
accepted treatment
- if there is already an accepted treatment you give
that as your control + placebo, and your experimental
drug + accepted treatment to another group so no
one is being withheld accepted tx
NDA new drug application- filed after clinical trials, can
take up to 3 years for approval due to volume/length
of applications
, what has helped speed up the NDA Prescription drug user fee act- now costs millions to
approval process? submit NDA, so this money is going to pay the
applications reviewers, allowing for more people to
be paid to review
but can create conflict of interest
what drugs are expedited? Brand new drugs with no others on the market and
drugs are in great need (ie. COVID-19 vaccine)
What say does the FDA have on drug can tell you if name is misleading or confusing when
name choice? it comes to preexisting drugs
for example, Losec 20 mg/day is too similar to Lasix
20 mg/day so losec had to be changed to Prilosec
off-label use when a drug proves effective tx for something that
differs from the one involved in original testing and
FDA approval
how is off-label drug use regulated? its not really... as long as its within the prescribers
scope to treat the disorder, a drug can be legally
prescribed for off label use
only thing you can't do is market the drug for the off-
label use
how can you market for off-label use? you can't unless you get another indication by
conducting 1 or more phase 3 clinical trials proving
this drug is better than other ones on the market
already
how long does a drug patent last? 20 years from drug discovery phase
Verified Solutions
Save
Terms in this set (190)
What are the 4 components to the 1. drug discover (5 years)
drug development process and how 2. Pre clinical (1.5 years)
long on average does each take? 3. clinical trials (6 years)
4. Drug approval (1-3 years)
how many compounds typically start start with around 5000 compounds in the discovery
the drug development process, how phase, drops to 250 in pre-clinical, 5 in clinical trials,
does this number change throughout? and 1 drug gets approved
How much does it cost on average to 1-2 billion dollars
bring a new drug into this world?
what is one of the most recent trends an increase in partnerships/collaborations between
in drug development? industries, "sharing development ideas" in order to
succeed together, otherwise buy out competition
How are drugs priced? whatever the market will permit, companies need to
make enough money off them to recover their initial
investment and have money left over to make new
drugs
What part of the drug development drug discovery, by screening compounds, currently
process would AI have the most 1000s of drugs are tested to find which would be
impact on? best to go into pre-clinical testing
What are the two concerns during safety of the drugs and pharmacokinetics (drug
pre-clinical phase? administration, dosage, half life, elimination)
,IND Apl (+when) investigational new drug application that happens
after the pre-clinical phase and before the clinical
phase
An FYI to the FDA of what you plan to do, explaining
your pre-clinical work and how it will advance into
clinical trial, FDA can give advice before you start
clinical trials however if you don't hear from them in
30 days you can proceed, but FDA can still give you
feedback after
phase 1 clinical trial Smaller population (20-100), usually younger healthy
individuals, still just testing safety and
pharmacokinetics to prove drug is doing what we
want it to in humans as it was in animals, still not
worried about efficacy
phase 2 clinical trials when efficacy/pharmacodynamics begins to be
tested (still concerned about safety and
pharmacokinetics too)
- involves 100-500 subjects, now including people
with disease the drug is for
phase 3 clinical trials - proof of concept- large randomized controlled
studies occur here
- studies use a placebo if there is not another
accepted treatment
- if there is already an accepted treatment you give
that as your control + placebo, and your experimental
drug + accepted treatment to another group so no
one is being withheld accepted tx
NDA new drug application- filed after clinical trials, can
take up to 3 years for approval due to volume/length
of applications
, what has helped speed up the NDA Prescription drug user fee act- now costs millions to
approval process? submit NDA, so this money is going to pay the
applications reviewers, allowing for more people to
be paid to review
but can create conflict of interest
what drugs are expedited? Brand new drugs with no others on the market and
drugs are in great need (ie. COVID-19 vaccine)
What say does the FDA have on drug can tell you if name is misleading or confusing when
name choice? it comes to preexisting drugs
for example, Losec 20 mg/day is too similar to Lasix
20 mg/day so losec had to be changed to Prilosec
off-label use when a drug proves effective tx for something that
differs from the one involved in original testing and
FDA approval
how is off-label drug use regulated? its not really... as long as its within the prescribers
scope to treat the disorder, a drug can be legally
prescribed for off label use
only thing you can't do is market the drug for the off-
label use
how can you market for off-label use? you can't unless you get another indication by
conducting 1 or more phase 3 clinical trials proving
this drug is better than other ones on the market
already
how long does a drug patent last? 20 years from drug discovery phase
