STUDYGUIDE
Questions and Answers latest update 2025
Biopharmaceutics --- correct answer ---The science that examines the
relationship between the physicochemical properties of the drug, its dosage
form and route of administration and how it could affect a drug.
Bioavailability --- correct answer ---A measure of systemic availability of a
drug
Multi-source --- correct answer ---Me-too product
"Generic"
Could be branded or unbranded
Innovator --- correct answer ---Originator
First to be patented (20years)
"Branded"
Prototype
, Biopharmaceutucs Classification System (BCS) --- correct answer ---A
scientific framework for drug classification based on their aqueous
solubility and intestinal permeability.
Pharmaceutical Equivalents --- correct answer ---Drug product with the
same active pharmaceutcal ingredients, dosage form, dosage strength, mode
of administration, standard of quality (test identity, assay, dissolution)
Biopharmaceutics --- correct answer ---Study of the in vitro effect of drug
products on drug delivery ubder normal or pathologic conditions
Pharmaceutical alternatives --- correct answer ---Drug product that may
differ in chemical form of active pharmaceutical ingredients, dormsage
strength & dosage form.
absolute bioavailability --- correct answer ---The extent or fraction of drug
absorbed upo E.V. administration in comparison to the dose size
administered.
In vitro equivalence testing --- correct answer ---Dissolution test that
includes comparison of dissolution profiles of a generic and comparator
product using 3 medias
pH 1.2 --- correct answer ---Media for stomach