PTCB MTM Exam Preparation 2024
Questions & Answers 100% Correct!!
Pharmaceutical equivalent - ANSWERcontain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
pharmaceutical alternatives - ANSWERare different salts, esters, or complexes (e.g. tetracycline
hydrochloride and tetracycline phosphate complex)
have different dosage forms (e.g. capsules vs. tablets) or strengths
the rate and extent of absorption of the test drug (usually a generic) are not significantly different
from those of the reference drug (brand) when they are administered at the same molar dose under
similar conditions; in either a single dose or multiple doses
OR the extent of absorption of the test drug does not differ significantly from that of the reference
drug
the rate of absorption may differ, but this is intentional, is reflected in the product labeling, is not
essential to the attainment of effective body drug concentrations during chronic use, and is
considered medically insignificant for the drug (e.g. a generic may need to be taken twice daily but
with regular use, its effects would be equivalent)
data are generally not available for FDA to make the determination of tablet to capsule
bioavailability - ANSWERrefers to the rate and extent to which an active ingredient is absorbed after
administration and becomes available at the drug's site of acction
bioequivalence - ANSWERdetermined based on the drug's pharmacokinetics
biosimilars - ANSWERnot "generic copies" because they are biologic products derived from a
different cell line. According to the FDA:
Questions & Answers 100% Correct!!
Pharmaceutical equivalent - ANSWERcontain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
pharmaceutical alternatives - ANSWERare different salts, esters, or complexes (e.g. tetracycline
hydrochloride and tetracycline phosphate complex)
have different dosage forms (e.g. capsules vs. tablets) or strengths
the rate and extent of absorption of the test drug (usually a generic) are not significantly different
from those of the reference drug (brand) when they are administered at the same molar dose under
similar conditions; in either a single dose or multiple doses
OR the extent of absorption of the test drug does not differ significantly from that of the reference
drug
the rate of absorption may differ, but this is intentional, is reflected in the product labeling, is not
essential to the attainment of effective body drug concentrations during chronic use, and is
considered medically insignificant for the drug (e.g. a generic may need to be taken twice daily but
with regular use, its effects would be equivalent)
data are generally not available for FDA to make the determination of tablet to capsule
bioavailability - ANSWERrefers to the rate and extent to which an active ingredient is absorbed after
administration and becomes available at the drug's site of acction
bioequivalence - ANSWERdetermined based on the drug's pharmacokinetics
biosimilars - ANSWERnot "generic copies" because they are biologic products derived from a
different cell line. According to the FDA:
