Bioequivalence Flashcards
What is the official name of the orange book?
Approved drug products with therapeutic equivalence evaluations
What is the purpose of the orange book?
identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act).
To provide FDA-approved drug products and therapeutic equivalence evaluations for generic substitution.
How do you interpret data in the Orange Book?
It includes active ingredients, dosage forms, therapeutic equivalence ratings, and patent/exclusivity details.
What is meant by formulary?
This is what is approved for sale or use in institution.
Therapeutic Equivalence-Related Terms
Define Pharmaceutical Equivalents.
Pharmaceutical equivalents are drug products in identical dosage forms and route of administration that contain identical amounts of the identical active drug ingredient,
i.e., the same salt or ester of the same therapeutic moiety
They may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time, and, within certain limits, labeling
or
Drugs with the same active ingredient, dosage form, and strength but possibly different inactive ingredients.
Therapeutic Equivalence-Related Terms
Define Pharmaceutical Alternatives.
Pharmaceutical alternatives are drug
products that contain the identical therapeutic moiety, or its precursor, but
not necessarily in the same amount or dosage form, or the same salt or ester
(e.g., tetracycline hydrochloride, 250 mg capsules vs. tetracycline phosphate
complex, 250 mg capsules; quinidine sulfate, 200 mg tablets vs. quinidine
sulfate, 200 mg capsules
or
Drugs with the same active ingredient but in different dosage forms, salt, ester or strengths.
Therapeutic Equivalence-Related Terms
Define Therapeutic Equivalents.
drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
or
Drugs that are both pharmaceutical equivalents and bioequivalent, meaning they have the same clinical effect.
or
A subset of pharmaceutical equivalents that are also proven to be bioequivalent and same clinical effect
What are therapeutic alternatives?
Therapeutic alternatives are medicines that are chemically different from the one prescribed (used) but which have the same clinical effect. Therapeutic alternatives are not to be confused with generics.
or
Drugs with different active ingredients ( may be in different classes) but similar therapeutic effects.
Therapeutic Equivalence-Related Terms
Define Strength.
Strength refers to the amount of drug substance contained in, delivered, or deliverable from a drug product
includes
1. the total quantity of drug substance in mass or units of activity in a dosage unit or container closure
2. the concentration of the drug substance in mass or units of activity per unit volume or mass
Therapeutic Equivalence-Related Terms
Define Bioavailability.
What is relative bioavailability?
What is absolute bioavailability?
the rate and extent to which the active ingredient or active moiety is absorbed from a drug product becomes available at the site of drug action
A comparison of drug absorption between different formulations or routes of administration.
The percentage of a drug that reaches systemic circulation compared to IV administration (100%
Therapeutic Equivalence-Related Terms
Define Bioequivalence.
is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions
What is a bioequivalence requirement?
A standard that ensures a generic drug has similar bioavailability to the brand-name drug, ensuring the same therapeutic effect.
What are bioequivalent drug products?
Drugs with the same active ingredient, dosage form, and strength that exhibit similar bioavailability when administered in the same way.
What is an Abbreviated New Drug Application (ANDA)?
An application for FDA approval of a generic drug, demonstrating bioequivalence to a brand-name drug without requiring full clinical trial.
What is a biosimilar drug?
biologic drugs are made from living cells and they cannot be copied exactly like generics copy brand names. therefore they are termed biosimilar. e..g insulin
biological product that is highly similar to an already approved reference (original) biologic drug, with no clinically meaningful differences in terms of:Safety. Purity and Potency (effectiveness)
What is a brand-name drug?
What is the chemical name of a drug?
What is a generic drug name?
The proprietary name given to a drug by its manufacturer, protected by trademarks.
The name that describes the drug’s molecular structure, used in scientific and medical contexts.
The official, non-proprietary name assigned to a drug, the same across all manufacturers.
What is a drug product?
What is drug product performance?
What is a drug substance?
A finished dosage form (tablet, capsule, injection) containing a drug substance and inactive ingredients.
How well a drug delivers the active ingredient in terms of stability, bioavailability, and therapeutic effect.
The active pharmaceutical ingredient (API) that produces the intended therapeutic effect.
What is equivalence in pharmaceuticals?
The similarity between two drug products in terms of quality, safety, and efficacy.
What are multisource drug products?
Drugs available from multiple manufacturers, typically generic versions of brand-name drugs.
What is generic substitution?
What is pharmaceutical substitution?
What is therapeutic substitution?
Replacing a brand-name drug with an FDA-approved generic equivalent.
Replacing a drug with a different chemical form, salt, ester or dosage form of the same drug
Replacing a prescribed drug with a different drug in the same class that has the same therapeutic effect.
What is a Reference Listed Drug (RLD)?
The original brand-name drug used as the standard for generic approval.
