PTCB MTM Exam Preparation
Pharmaceutical equivalent – answer contain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
pharmaceutical alternatives - answer are different salts, esters, or complexes (e.g.
tetracycline hydrochloride and tetracycline phosphate complex)
have different dosage forms (e.g. capsules vs. tablets) or strengths
data are generally not available for FDA to make the determination of tablet to capsule
bioavailability - answer refers 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
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)
biosimilars - answernot "generic copies" because they are biologic products derived
from a different cell line. According to the FDA:
subsequent versions of an innovative biopharmaceutical product
highly similar to the already FDA-approved biological "reference point"
have been shown to have no clinically meaningful differences in safety, purity, and
potency from the reference product
(e.g. Lantus and Semglee)
Pharmaceutical equivalent – answer contain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
pharmaceutical alternatives - answer are different salts, esters, or complexes (e.g.
tetracycline hydrochloride and tetracycline phosphate complex)
have different dosage forms (e.g. capsules vs. tablets) or strengths
data are generally not available for FDA to make the determination of tablet to capsule
bioavailability - answer refers 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
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)
biosimilars - answernot "generic copies" because they are biologic products derived
from a different cell line. According to the FDA:
subsequent versions of an innovative biopharmaceutical product
highly similar to the already FDA-approved biological "reference point"
have been shown to have no clinically meaningful differences in safety, purity, and
potency from the reference product
(e.g. Lantus and Semglee)
