What is bioavailability and bioequivalence studies?

Bioavailability is defined as relative amount of drug from an administered dosage which enters the systemic circulation and the rate at which the drug appears in the systemic circulation. Bioequivalence studies are used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug.

Is bioequivalence and bioavailability the same?

Bioequivalence is Just a comparison of the bioavailability of two identical products. The rate and extent of absorption is called as bioavailability. Bioequivalence is the comparison of bioavailability between two drug formulations.

How long does a bioequivalence study take?

9 days (approximately) including the wash-out period of 48 hours and the time between last blood sampling in the last period to the final examination tests.

What is BA study?

BA/BE (Bioavailability & Bioequivalence) Studies. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

What is a bioequivalence study?

15.5. Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters.

What is the purpose of bioequivalence studies?

The purpose of bioequivalence (BE) studies is to identify pharmaceutical equivalents or alternatives to be used interchangeably for the same therapeutic effect as a previously marketed drug. In general, we perform bioequivalence testing by comparing the bioavailability of the test product with the reference product.

What is the purpose of bioavailability studies?

Bioavailability studies are drug product performance studies used to define the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacture process of the drug product (dosage form).

What are the objectives of bioavailability studies?

Objectives of Bioavailability studies : During primary stages of development of suitable dosage forms of new drug entity . Determination of influence of excipients , patient related factors & possible interaction with other drugs on the efficiency of absorption . Development of new formulations of existing drugs .

What is AUC in bioavailability?

AUC and bioavailability. In pharmacokinetics, bioavailability generally refers to the fraction of drug absorbed systemically, and is thus available to produce a biological effect. This is often measured by quantifying the “AUC”. In order to determine the respective AUCs, the serum concentration vs.

What is relative bioavailability?

Relative bioavailability and bioequivalence. In pharmacology, relative bioavailability measures the bioavailability (estimated as the AUC) of a formulation (A) of a certain drug when compared with another formulation (B) of the same drug, usually an established standard, or through administration via a different route.

What does bioequivalence mean?

“Bioequivalence” means that the active ingredient of 2 drug products has the same rate and extent of absorption. When it acts on its target — for example, a receptor in the brain — the brand-name and the generic drug should deliver the same amount of active ingredient to the target site. There are different ways of assessing bioavailability.

What is the bioavailability of drugs?

Bioavailability refers to the extent and rate at which the active moiety (drug or metabolite) enters systemic circulation, thereby accessing the site of action. Bioavailability of a drug is largely determined by the properties of the dosage form, which depend partly on its design and manufacture.