What is a comparative bioavailability study?
What is a comparative bioavailability study?
A comparative bioavailability study refers to the comparison of bioavailabilities of different formulations of the same drug or different drug products. As indicated in Chow and Liu (2008), the definition of bioavailability has evolved over time with different meanings by different individuals and organizations [1].
What is the difference between bioavailability study and bioequivalence study?
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.
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 is meant by 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.
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 relative bioavailability?
“Relative” bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to a different formulation (non-IV) such as oral solution, reference formulation, etc. Relative bioavailability is commonly used when an IV formulation does not exist or cannot be made.
What do you mean by bioavailability and bioequivalence?
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 concept of bioavailability?
The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance that is taken by mouth can be absorbed and used by the body.