Who bioequivalence guidelines?
Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and their bioavailabilities, in terms of rate (Cmax and tmax ) and extent of absorption (area under the curve (AUC)), after administration of the same molar dose under the same conditions, are similar …
What is bioequivalence and bioavailability?
Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. It is measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine where equality is 1.
What is the difference between bioavailability and bioequivalence studies?
Bioavailability studies focus on determining the process and time frame by which a drug substance is released from the oral dosage form and moves to the site of action. On the other hand, bioequivalence studies focus on the performance of the drug product and usually involve comparisons of two drug products: T and R.
When bioavailability and bioequivalence studies are carried out?
A bioequivalence study is usually carried out for generic drug product. The study evaluates clinical differences in the bioavailability of two distinct drugs. These studies are conducted to assess the efficacy of a new drug product which may have a few different excipients or inactive ingredients.
What is bioequivalence criteria?
The currently accepted test is often called “bioequivalence”. The bioequivalence test states that we can conclude that two treatments are not different from one another if the 90% confidence interval of the ratio of a log-transformed exposure measure (AUC and/or Cmax) falls completely within the range 80-125%.
Why bioequivalence studies are done?
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.
What is BA and BE in clinical trials?
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.