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Pharm 124 Midterm Exam Questions and
Answers 100% Solved
Why might glycerin be included in tinctures? - ✔✔to increase solubility and
stability of the active agents in the tincture
What is the drug approval process? - ✔✔Manufacturer submits a Clinical
Trial Application for authorization to conduct clinical trial in Canada and
submit an NDS to health Canada to establish that a drug is safe, effective,
and of high quality
What is a generic drug? - ✔✔copy of a brand name product; contain same
medical ingredients as the brand name drug and are considered
bioequivalent to the reference product; excipients may be different from
brand name
What percentage of prescriptions do generic drugs represent? - ✔✔70%
but about 20% of money spent on prescription drugs
What is bioavaliability? - ✔✔measure of the rate and extent to which the
therapeutically active ingredient in a drug product is absorbed into the body
How is bioavailability assessed? - ✔✔1 - blood concentration over time
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2 - maximum concentration of active ingredient in the blood stream
What is bioequivalence? - ✔✔property wherein two drugs with identical
active ingredients or two different dosage forms of the same drug possess
similar bioavailability and produce the same effect at the site of
physiological activity
How do we know we can trust approved generic drugs? - ✔✔companies
must submit an abbreviated new drug application (ANDA) which must show
rigorous scientific evidence regarding safety and efficacy, bioequivalence,
details on production of the generic drug, not usually necessary to repeat
extensive clinical trials
When is it not ok to substitute generic for brand name? - ✔✔FDA indicates
over 25 NTI drugs that cant be substituted for generic as it is risky to switch
a drug once a patient is already stable
What is a counterfeit drug? - ✔✔A medication that is produced and sold
with the intent to deceptively represent its origin, authenticity or
effectiveness; may not contain active ingredients, contains insufficient
quantity of active ingredients, sold with inaccurate/fake packaging, contains
entirely incorrect active ingredients
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What characteristics are counterfeit drugs usually classified by? - ✔✔re-
labeled drugs that were previously expired defective or otherwise deemed
unfit for use, active ingredient is fraudulently diluted, active ingredient in
adulterated, active ingredient is substituted, and falsely labeled substances
of any composition wherein active ingredient is completely misrepresented
Why are counterfeit drugs a concern to Canadians? - ✔✔There have been
cases of counterfeit drugs reaching Canadian patients, Canadians might
purchase counterfeit drugs online, and they contain less regulated 'natural
products' and 'supplements' which can be harmful and come from foreign
sources
What are tips for buying drugs safely online? - ✔✔Don't buy from online
seller that doesn't require a prescription; if you don't have a prescription
don't deal with a website that will provide one based on a online
questionnaire
What signs to watch out for with counterfeit drugs? - ✔✔labels with spelling
mistakes, packaging with poor printing quality, labels with no DIN or natural
product number and products having different taste or flavor than the
product normally used
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What does analytical testing for fake drugs look for? - ✔✔tests for drug
identity, concentration purity and adulterants or contaminants done with
wet-chemical procedures such as thin layer chromatography
Why do we need dosage forms? - ✔✔convenient and safe delivery of
accurate dosage, avoid drug degradation, improve palatability, provide in a
form that can be administered, and to control drug release rate
What are dosage forms? - ✔✔means by which a drug molecules are
delivered to sites of action within the body
What dosage forms are avaliable? - ✔✔tablets, capsules, solutions,
suspensions, emulsions, powders, ointments, and creams
What are excipients and what role do they play? - ✔✔non-medical
ingredients that help drug remain stable, improve solubility, taste, etc.
What makes up the drug delivery systems? - ✔✔Drug and
excipients/delivery device
What considerations must there be to determine drug delivery systems? -
✔✔physiochemical properties of drug (solution, stability),
biopharmaceutical, and therapeutic considerations (time of onset, duration
of action, site of action, age, illness)
