Pharm 124 Bioavailability and Bioequivalence Exam Questions and Answers 100% Solved
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Course
Pharm 124
Institution
Pharm 124
Pharm 124 Bioavailability and
Bioequivalence Exam Questions and
Answers 100% Solved
What is a multisource drug product? - 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 Atorvastat...
What is a type of an in vitro drug performance test? - ✔✔Dissolution
profiles
What are bioavailability studies? - ✔✔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? - ✔✔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? - ✔✔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)
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