mtm detailed Flashcards
Pharmaceutical equivalent (3)
contain the same active ingredient(s)
have the same dosage form and route of administration
are identical in strength or concentration.
pharmaceutical alternatives (3)
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
refers to the rate and extent to which an active ingredient is absorbed after administration and becomes available at the drug’s site of action
bioequivalence
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
biosimilars
have been shown to have no clinically meaningful differences in safety, purity, and potency from the reference product
The Orange Book
The FDA’s list of therapeutic drug equivalence-drugs containing the same active ingredients
Therapeutic equivalence (5)
The FDA criteria require that they:
(1) are approved drugs shown to be safe and effective; expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling
(2) are pharmaceutical equivalents which (a) contain identical amounts of the same active ingredient in the same dosage form and route of administration, and (b) meet required standards of strength, quality, purity, and identity
(3) are bioequivalent - either the drugs do not present a known or potential bioequivalence problem and meet an acceptable in vitro standard, or may present a known or potential bioequivalencce problem but it is within acceptable bioequivalence standards
(4) have adequate labeling
(5) are manufactured in compliance with current Good Manufacturing Practice regulations
“A” rating
drugs that are therapeutically equivalent to the reference drug, with no known bioequivalence problems
AA
conventional dosage forms
AN
solutions and powders for aerosolization
AO
Injectable oil solutions
AP
injectable aqueous / IV solutions
AT
topical products
AB
therapeutically equivalent to each other; known or potential bioequivalence problems may exist but have been found to meet standards for bioequivalence
B
not therapeutically equivalent to other pharmaceutical products; actual or potential bioequivalence problems have not been resolved
