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PTCB MTM Exam Preparation Questions & Answers (RATED A+)
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"A" rating - ANSWERdrugs that are therapeutically equivalent to the reference drug, with no known bioequivalence problems "AB" rating - ANSWERtherapeutically equivalent to each other; known or potential bioequivalence problems may exist but have been found to meet standards for bioequivalence ...

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  • October 17, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • ptcb mtm exam preparation questions answers rat
  • ptcb mtm exam stuvia 2024
  • a rating answerdrugs that are therapeutically
  • ab rating answertherapeutically equivalent to

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PTCB MTM Exam Preparation Questions &
Answers (RATED A+)

"A" rating - ANSWERdrugs that are therapeutically equivalent to the reference drug, with no known
bioequivalence problems



"AB" rating - ANSWERtherapeutically equivalent to each other; known or potential bioequivalence
problems may exist but have been found to meet standards for bioequivalence



"B" rating - ANSWERnot therapeutically equivalent to other pharmaceutical products; actual or
potential bioequivalence problems have not been resolved



A1C - ANSWERglycosylated hemoglobin



normal <5.7%

prediabetes = 5.7% - 6.4%

diabetes >6.5%



A1C = BG

7=152

8-183

9=212

10=240



AA - ANSWERconventional dosage forms



AN - ANSWERsolutions and powders for aerosolization



AO - ANSWERInjectable oil solutions

, AP - ANSWERinjectable aqueous / IV solutions



AT - ANSWERtopical products



B* - ANSWERrequires FDA investigation to review equivalence



BC - ANSWERExtended-release dosage forms (capsules, injectables and tablets)



BD - ANSWERactive ingredient and dosage forms with DOCUMENTED bioequivalence problems



BE - ANSWERdelayed-release oral dosage forms



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



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

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