Pharm Exam 1 (Part 1-5) – Questions Answered With
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Terms in this set (211)
What is the difference between Pharmacokinetics is what the body does to the drug
pharmacokinetics and (absorbed, metabolized, excreted, etc), where as
pharmacodynamics? pharmacodynamics is what the drug does to the
body
What three names are drugs identified -chemical name
by? -generic name
-trade name(s)
What are the differences between a A drug's chemical name is the first name given to the
drug's chemical name versus its drug based on its chemical make-up. This is a long,
generic name versus its trade name(s) awkward, hard to pronounce name usually. So, the
chemical name is shortened to a generic name which
is just a shorter, easier to pronounce version of the
chemical name. Trade names are the names in which
the drug is marketed under (different brands
essentially).
A drug's _____ name is often shortened chemical; generic
or condensed to form the drug's ______
name?
Lasix is an example of a ______ name, trade; chemical; generic
whereas 4-chloro-N-furfuryl-5-
sulffamoylanthranilic acid is the ____
name and furosemide is the _____ name
,What can be potential problems with they can sound and be spelled similarly which can
trade names? result in confusion (with prescribing, documenting
etc). Also, trade names do not usually provide
information in the name on what the drug is for.
What are generic equivalents? A patent for a drug has a finite lifespan, and when it
expires other companies can market the drug. They
are typically less expensive than brand-name
products
What criteria deems generic - same type and amount of active ingredient
equivalents to be bioequivalent to -uses same administration route
brand-name product? -same pharmacokinetic profile
-found to have same therapeutic effects
What is the entity that oversees drug FDA
testing and approval and also
responsible for drug classification?
What are the phases of drug testing? First, Preclinical (animal trials). Then 3 phases of
clinical trials, and then it is approved for marketing
under post-marketing surveillance which is phase 4
What does phase 1 of drug testing Drug is tested on HEALTHY individuals (people
involve? without the condition the drug is supposed to treat).
Done to get a sense of the side-effects, safe dosing
range, and to see if it will be acceptable in human
population. Usually last up to one year or less
What does phase 2 of drug testing Drug is tested on a SMALL sample of people with the
involve? condition. The sample size can vary, but is usually
around 200-300 people. This phase lasts about 2
years and its purpose is to see if the drug actually
has beneficial effects on the condition.
, What does phase 3 of drug testing Drug is tested on LARGER sample, around 2000-
involve? 3000 people with the condition. Lasts for 3 years.
Purpose of this phase is to test if drug is really SAFE.
If drug passes this phase then it is approved for
marketing.
What does phase 4 of drug testing Occurs after drug has been approved for marketing.
involve? Surveillance of drug is continued through phone
interviews, questionnaires etc to see if anything was
missed in the clinical trials.
What are the odds of drug approval? for every 5,000 that enter preclinical trials, only 5
proceed to clinical trials, and out of these 5 only 1 is
approved.
What is expedited review? A fast track/priority review if the drug has
exceptional need or beneficial effects. Saves time,
but drug testing must often continue even after
approval in these cases.
What are orphan drugs? drugs that are indicated for a small population (for
example, under 200,000 people in USA) so FDA
arranges the funding to subsidize drug development.
This applies to drugs needed for rare diseases
About how long does it typically take 7-9 years if it survives all clinical trials
for a drug to undergo testing ad make
it to market?
How does the FDA's approval FDA requires proof that the drug is safe AND
requirements differ from those in effective whereas in some other countries there only
other countries? has to be proof that the drug is SAFE
What is done if there was a failure to The drug is either taken off the market OR it is made
identify serious side effects before a known to public because benefits of drug may still
drug is approved for marketing? outweigh risks for some patients. Drugs in this case
are given Black Box Warning in which it lists what the
problems are with the drug and who should not use
it
Expert Insight
Save
Terms in this set (211)
What is the difference between Pharmacokinetics is what the body does to the drug
pharmacokinetics and (absorbed, metabolized, excreted, etc), where as
pharmacodynamics? pharmacodynamics is what the drug does to the
body
What three names are drugs identified -chemical name
by? -generic name
-trade name(s)
What are the differences between a A drug's chemical name is the first name given to the
drug's chemical name versus its drug based on its chemical make-up. This is a long,
generic name versus its trade name(s) awkward, hard to pronounce name usually. So, the
chemical name is shortened to a generic name which
is just a shorter, easier to pronounce version of the
chemical name. Trade names are the names in which
the drug is marketed under (different brands
essentially).
A drug's _____ name is often shortened chemical; generic
or condensed to form the drug's ______
name?
Lasix is an example of a ______ name, trade; chemical; generic
whereas 4-chloro-N-furfuryl-5-
sulffamoylanthranilic acid is the ____
name and furosemide is the _____ name
,What can be potential problems with they can sound and be spelled similarly which can
trade names? result in confusion (with prescribing, documenting
etc). Also, trade names do not usually provide
information in the name on what the drug is for.
What are generic equivalents? A patent for a drug has a finite lifespan, and when it
expires other companies can market the drug. They
are typically less expensive than brand-name
products
What criteria deems generic - same type and amount of active ingredient
equivalents to be bioequivalent to -uses same administration route
brand-name product? -same pharmacokinetic profile
-found to have same therapeutic effects
What is the entity that oversees drug FDA
testing and approval and also
responsible for drug classification?
What are the phases of drug testing? First, Preclinical (animal trials). Then 3 phases of
clinical trials, and then it is approved for marketing
under post-marketing surveillance which is phase 4
What does phase 1 of drug testing Drug is tested on HEALTHY individuals (people
involve? without the condition the drug is supposed to treat).
Done to get a sense of the side-effects, safe dosing
range, and to see if it will be acceptable in human
population. Usually last up to one year or less
What does phase 2 of drug testing Drug is tested on a SMALL sample of people with the
involve? condition. The sample size can vary, but is usually
around 200-300 people. This phase lasts about 2
years and its purpose is to see if the drug actually
has beneficial effects on the condition.
, What does phase 3 of drug testing Drug is tested on LARGER sample, around 2000-
involve? 3000 people with the condition. Lasts for 3 years.
Purpose of this phase is to test if drug is really SAFE.
If drug passes this phase then it is approved for
marketing.
What does phase 4 of drug testing Occurs after drug has been approved for marketing.
involve? Surveillance of drug is continued through phone
interviews, questionnaires etc to see if anything was
missed in the clinical trials.
What are the odds of drug approval? for every 5,000 that enter preclinical trials, only 5
proceed to clinical trials, and out of these 5 only 1 is
approved.
What is expedited review? A fast track/priority review if the drug has
exceptional need or beneficial effects. Saves time,
but drug testing must often continue even after
approval in these cases.
What are orphan drugs? drugs that are indicated for a small population (for
example, under 200,000 people in USA) so FDA
arranges the funding to subsidize drug development.
This applies to drugs needed for rare diseases
About how long does it typically take 7-9 years if it survives all clinical trials
for a drug to undergo testing ad make
it to market?
How does the FDA's approval FDA requires proof that the drug is safe AND
requirements differ from those in effective whereas in some other countries there only
other countries? has to be proof that the drug is SAFE
What is done if there was a failure to The drug is either taken off the market OR it is made
identify serious side effects before a known to public because benefits of drug may still
drug is approved for marketing? outweigh risks for some patients. Drugs in this case
are given Black Box Warning in which it lists what the
problems are with the drug and who should not use
it
