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Pharm 124 Midterm Exam With Questions And Verified Detailed Answers
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Pharm 124 Midterm Exam With Questions AndVerified Detailed Answers
Why might glycerin be included in tinctures? - ANSWER to increase solubility and
stability of the active agents in the tincture
What is the drug approval process? - ANSWER 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? - ANSWER 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? - ANSWER 70% but
about 20% of money spent on prescription drugs
What is bioavaliability? - ANSWER 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? - ANSWER 1 - blood concentration over time
2 - maximum concentration of active ingredient in the blood stream
What is bioequivalence? - ANSWER 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? - ANSWER 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? - ANSWER 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? - ANSWER 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
What characteristics are counterfeit drugs usually classified by? - ANSWER 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? - ANSWER 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? - ANSWER 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? - ANSWER 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
What does analytical testing for fake drugs look for? - ANSWER 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? - ANSWER 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? - ANSWER means by which a drug molecules are delivered to
sites of action within the body
What dosage forms are avaliable? - ANSWER tablets, capsules, solutions, suspensions,
emulsions, powders, ointments, and creams
What are excipients and what role do they play? - ANSWER non-medical ingredients that
help drug remain stable, improve solubility, taste, etc.
What makes up the drug delivery systems? - ANSWER Drug and excipients/delivery
device
What considerations must there be to determine drug delivery systems? - ANSWER
physiochemical properties of drug (solution, stability), biopharmaceutical, and
therapeutic considerations (time of onset, duration of action, site of action, age, illness)
What are the steps in formulation development? - ANSWER Pre-formulation studies
(drug characterization, drug/excipient interaction, choice of excipients), formulation
(process variables and product parameters), and testing in a biological system
(bioavailability, bio-distribution, therapeutic response, and toxicological testing)
What are the types of solid dosage forms? - ANSWER powders, capsules, tablets,
modified release dosage forms
What are advantages of solid dosage forms? - ANSWER unit dose, cost of shipping, no
breakage or leakage, masking taste less difficult, more portable, require less space per
dose, good physical and chemical stability, and elegant distinctive appearance which
has a high patient acceptability
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