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Pharm 124 Bioavailability and Bioequivalence Exam
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Pharm 124 Bioavailability and Bioequivalence ExamWhat is a multisource drug product? - ANSWER A drug product that contains the same
active drug substance in the same dosage form and is marketed by more than one
pharmaceutical manufacturer
Example:
10 mg Atorvastatin tablet by Pfizer
10 mg Atorvastatin tablet by Mylan
Single-source drug products - ANSWER Are usually brand name (innovator) drug
products
Drug product performance, in vivo - ANSWER The release of the drug substance from
the drug product leading to bioavailability of the drug substance
Biopharmaceutics - ANSWER The study of pharmaceutical formulation variables on the
performance of a drug product in vivo
What are the two types of in vivo drug product performance tests? - ANSWER 1.
Bioavailability studies
2. Bioequivalence studies
What is a type of an in vitro drug performance test? - ANSWER Dissolution profiles
What are bioavailability studies? - ANSWER Drug product performance studies used to
define the effect of changes in the:
1. Physiochemical properties of the drug substance
, 2. The formulation of the drug
3. The manufacture process of the drug product (dosage form)
When are Bioavailability studies performed? - ANSWER They are performed for both:
1. Approved active drug ingredients
2. Therapeutic moieties not yet approved for marketing by the FDA
What are bioequivalence studies? - ANSWER Drug product performance tests that
compare the bioavailability of the same active pharmaceutical ingredient from one drug
product (test) to a second drug product (reference)
What are dissolution and drug release tests? - ANSWER They are in vitro tests that
measure the rate and extent of dissolution or release of the drug substance from a drug
product, usually in an aqueous medium under specified conditions
What is SUPAC? - ANSWER -Stands for Scale-Up and Post-Approval Change
-Changes to the formulation after the drug product is approved by the FDA and
marketed
SUPAC could include a change in? - ANSWER -The supplier of the active ingredient
-The formulation
-Manufacturing process and/or site
What needs to be proven or demonstrated for SUPAC? - ANSWER You need to
demonstrate via in vivo bioequivalence studies or in vitro dissolution profiles that drug
product performance is the same before and after the SUPAC change
What is bioavailability? - ANSWER -The relative amount of an administered dose that
reaches the general circulation and the rate at which this occurs
-Describes the rate and extent to which the active drug ingredient or therapeutic
ingredient is absorbed from a drug product and becomes available at the site of drug
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