"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
...
"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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