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8 Cards in this Set
- Front
- Back
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It is possible for two drugs to be:
pharmaceutical but not therapeutic equivalents therapeutic but not pharmaceutical equivalents therapeutic equivalents but not bioequivalent drugs all of the above are possible |
pharmaceutical but not therapeutic equivalents
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In order to be a therapeutic equivalent a drug alternative must be :
I. pharmaceutical equivalents II. bioequivalent III. DESI drugs IV. synthetic drugs I only I & II only I, II, & III only I, II, III, & IV |
I & II only
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Drugs which have no significant differences in rate and extent of absorption are called:
therapeutically equivalent pharmaceutical alternatives bioequivalent DESI drugs |
bioequivalent
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In a bioequivalence study an applicant drug can display differences within the range of ________ and still be deemed to be bioequivalent.
-10%/+10% -20%/+15% -20%/+30% -20%/+25% |
-20%/+25%
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A drug with an orange book rating of "AT" is rated to be a(n):
equivalent tablet non-equivalent tablet equivalent topical product non-equivalent topical product |
equivalent topical product
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The DESI review covered drugs which were:
in use prior to the requirement of proving efficacy before NDA approval in use prior to 1938 deemed to be ineffective in the top 300 drugs used in the United States |
in use prior to the requirement of proving efficacy before NDA approval
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DESI
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Drug Efficacy Study Implementation
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Equivalence ratings that begin with an "A" mean the drug has been found to be a therapuetic equivalent to the standard
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AA Drugs which are not considered to have the potential for equivalence problems
AB Drugs which have shown, through equivalence testing, they are equivalent AN Equivalent solutions and powders intended for aerosolization AO Equivalent injectible oil solutions whose active ingredient and oil vehicle are identical AP Equivalent injectible aqueous solutions and, in certain instances, intravenous non-aqueous solutions AT Equivalent topical products B* Indicates further testing is needed on a product who was already assigned an A or B code, but through new information a question involving equivalence was raised which requires more study BC Non-equivalence due to presumed difference in extended-release dosage forms (ie, sustained release) BD Drugs shown to be non-equivalent in bioequivalence studies BE Non-equivalent drug due to presumed differences in delayed release dosage forms (ie, enteric coating) BN Aerosol-Nebulizer drugs which are presumed to be non-equivalent BP Active ingredients which the FDA |
