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PTCB MTM Exam Preparation 2024 Questions & Answers 100% Correct!!

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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 tetracyc...

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  • October 17, 2024
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  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • PTCB MTM
  • PTCB MTM
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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:

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