Bioequivalence and Therapeutic Equivalence Ratings
How is the reference drug designated?
"+"; online it'll say yes or no
What does "B" signify as the first letter in the code?
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other pharmaceutically equivalent products
What does "A" signify as the first letter in the code?
Drug products that are considered to be therapeutically equivalent to other pharmaceutically equivalent products
describe the 80/20 rule
The FDA requires that a study be large enough to provide an 80% probability to detect a 20% difference in bioavailability
AB
actual or potential bioequivalence problems
BN
aerosol-nebulizer drug delivery system
B*
agency takes no position regarding TE
BE
delayed release oral dosage form
What does the third digit signify (not seen often)
denotes reference drug number (if there is more than 1)
BD
documented bioequivalence problems
BS
drug standard deficiences
BC
extended-release dosage form (controls release)
AP
injectable aq. solutions/IV non-aq solutions (parenteral)
AO
injectable oil solutions
BX
insufficient to determine TE
Drug in which the abbreviated new drug application (ANDA) drug is compared?
reference drug
What is defined as the drug product for which generic products are compared to usually the proprietor drug?
reference drug
Pharmaceutical equivalents
same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or conc.
Pharmaceutical alternatives
same therapeutic moiety, but are different salts, esters or complexes of that moiety or are different dosage forms or strengths
AN
solutions and powders for aerosolization- nebulizers
BR
suppositories/enemas for systemic absorption
What factors modify bioavailability?
-Physiochemical properties of the drug -Dosage form and excipients - Route of administration -Rate of absorption -Amount of drug absorbed -Pt characteristics
What are the two types of equivalence?
-Therapeutic equivalence -Pharmaceutical Equivalence
What are evaluation codes used for (2)?
-To quickly determine whether the Agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) -Provide additional information on the basis of FDA's evaluations (second letter)
What code means that the FDA does NOT consider the drug to be therapeutically equivalent to other pharmaceutically equivalent products because of insufficient basis to determine TE
B
Therapeutic equivalents must be (5)
1. Pharmaceutically equivalent 2. Safe/Effective 3. Bioequivalent 4. Adequate Labeling 5. GMP
What CI do the studies involved with the 80/20 rule utilize?
90% (80 and 125% of a drug)
Which code do drugs normally start as?
B* or BX
What is described as pharmaceutically equivalent or alternative products that display comparable bioavailability when studied under similar experimental conditions?
Bioequivalent drug products
What needs to be proved when making a generic bioequivalent of a brand?
Cmax, Tmax and AUC
What does the Second letter of the code signify?
Denotes appropriate dosage form
What implies that two brands of a drug product are expected to yield the same clinical result
Therapeutic equivalence
AT
Topical products
What is the importance of therapeutic equivalence?
With an increasing number of available Tx options, clinicians must frequently evaluate whether comparable therapies are equivalent in terms of efficacy and safety
Once therapeutics equivalence has been established, clinicians may select one therapy as the preferred Tx option because it offers other clinical benefits, such as...
a lower cost or a more convenient drug administration schedule
The rate and extent of ________ do not show a significant difference from the rate and extent of the reference drug
absorption
AA
conventional dosage form w/o bioequivalence problems (can be subbed with anything)-rare
Bioequivalent drug products are considered ______________ _________ or pharmaceutically alternatives that have equivalent bioavialability when studied under similar conditions
pharmaceutically equivalent
Bioequivalence is defined as...
the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalent or pharmaceutical alternatives become available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study
BT
topicals with bioequivalence issues