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 bioequivalence and bioavailability 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
.
What is a BE study?
Bioequivalence (BE) is defined as “
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 become available at the site of drug action when administered
at the same molar dose under similar conditions in …
What is BE study in pharma?
Bioequivalence (BE) studies are
most widely used methods to demonstrate therapeutic equivalence between two drug products
. … Bioequivalence studies are carried out to compare two medicinal products containing the same active substance.
What is a bioavailability study?
A comparative bioavailability study refers
to the comparison of bioavailabilities of different formulations of the same drug or different drug products
. … Two drug products are considered pharmaceutical equivalents if they contain identical amounts of the same active ingredient.
What are the 2 types of bioavailability?
Relative bioavailability and bioequivalence
When the standard consists of intravenously administered drug, this is known as absolute bioavailability (see above). Relative bioavailability is one of the measures used to assess bioequivalence (BE) between two drug products.
Why do we need bioequivalence studies?
Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is
the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs
.
What is Cmax and AUC?
Abstract. In bioequivalence studies, the
maximum concentration (Cmax)
is shown to reflect not only the rate but also the extent of absorption. Cmax is highly correlated with the area under the curve (AUC) contrasting blood concentration with time.
What type of study is a bioequivalence study?
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
. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
How do you test bioavailability?
Assessing bioavailability
Bioavailability is usually assessed by determining the area under the plasma concentration–time curve (AUC—see figure Representative plasma concentration–time relationship after a single ora…
What is drug bioavailability?
More accurately, bioavailability is
a measure of the rate and fraction of the initial dose of a drug that successfully reaches either
; the site of action or the bodily fluid domain from which the drug’s intended targets have unimpeded access.[1][2][3] For majority purposes, bioavailability is defined as the fraction of …
What is the full form of Cdsco?
The
Central Drugs Standard Control Organisation
(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.
What is the full form of ANDA?
An abbreviated
new drug application
(ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. … This demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug.
Which is an example of bioavailability?
Bioavailability is (1) the fraction of an administered dose of a drug that reaches the systemic circulation as intact drug (expressed as F) and (2) the rate at which this occurs. … For example,
orally administered morphine
has a bioavailability of about 25 percent due to significant first-pass metabolism in the liver.
What is absolute bioavailability?
“Absolute” bioavailability is
the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose
. The IV dose is assumed to be 100% bioavailable … since you are injecting the drug directly into the systemic circulation.
What is Biowaiver study?
INTRODUCTION. A Biowaiver means that
in vivo bioavailability and/
or bioequivalence studies may be waived (not considered necessary for product approval).
