Page 1 of 11 PTCB MTM Exam Preparation - Updated with Solution | All Covered PTCB MTM Exam Preparation.pdf
PTCB MTM Exam Preparation
contain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
Pharmaceutical equivalent
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
pharmaceutical alternatives
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
bioavailability
PTCB MTM Exam Preparation PTCB MTM Exam Preparation.pdf PTCB MTM Exam Preparation.pdf
, Page 2 of 11 PTCB MTM Exam Preparation - Updated with Solution | All Covered PTCB MTM Exam Preparation.pdf
determined 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)
bioequivalence
not "generic copies" because they are biologic products derived from a different
cell line. According to the FDA:
subsequent versions of an innovative biopharmaceutical product
PTCB MTM Exam Preparation PTCB MTM Exam Preparation.pdf PTCB MTM Exam Preparation.pdf
PTCB MTM Exam Preparation
contain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration
Pharmaceutical equivalent
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
pharmaceutical alternatives
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
bioavailability
PTCB MTM Exam Preparation PTCB MTM Exam Preparation.pdf PTCB MTM Exam Preparation.pdf
, Page 2 of 11 PTCB MTM Exam Preparation - Updated with Solution | All Covered PTCB MTM Exam Preparation.pdf
determined 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)
bioequivalence
not "generic copies" because they are biologic products derived from a different
cell line. According to the FDA:
subsequent versions of an innovative biopharmaceutical product
PTCB MTM Exam Preparation PTCB MTM Exam Preparation.pdf PTCB MTM Exam Preparation.pdf
