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