Biopharm FINALS - Bioavailability

A requirement imposed by the FDA for in vitro and/or in vivo testing of specified drug products, which must be satisfied as a condition for marketing.

Bioequivalence Requirement

Are pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability when studied under similar experimental conditions.

Bioequivalent drug products

Drug manufacturers must file an ____for approval to market a generic drug product.

Abbreviated New Drug Application (ANDA)

The finished dosage form that contains the active drug ingredient, generally, but not necessarily, in association with inactive ingredient.

Drug product

The process of choosing or selecting the drug product in a specified dosage form.

Drug product selection

Is the active pharmaceutical ingredient or component in the drug product that furnishes the pharmacodynamic activity

Drug substance

Relationship in terms of bioavailability, therapeutic response, or a set of established standards of one drug product to another.

Equivalence

The process of dispensing a different brand or an unbranded drug product in place of the prescribed drug product.

Generic substitution

Drug products that contain the same therapeutic moiety but as different salts, esters, or complexes.

Pharmaceutical Alternatives

Drug products in identical dosage forms that contain the same active ingredients, ie, the same salt or ester, are of the same dosage form,use the same route of administration, and are identical in strength or concentration.

● Exactly the same but manufactured by different companies

Pharmaceutical Equivalents

is identified by the FDA as the drug product on which an applicant relies when seeking approval of an ANDA. It is generally the brand name drug that has full New Drug Application (NDA).

Reference Listed Drug (RLD)

defined as the release of the drug substance from the drug product leading to bioavailability of the drug substance and leading to pharmacodynamic response.

● Bioequivalence studies are drug product performance tests.

Drug Product Performance (In Vivo)

the process of dispensing a pharmaceutical alternative for the prescribed drug product.

Pharmaceutical Substitution

drug products containing different active ingredients that are indicated for the same therapeutic or clinical objectives.

Therapeutic Alternatives

If they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

Therapeutic Equivalents

the process of dispensing a therapeutic alternative in place of the prescribed drug product.

Therapeutic Substitution