FDA may require in vivo or in vitro testing, or both, to measure the bioavailability or establish the BE of specific drug products. Applicants must conduct BE testing using the most accurate,...

In a bioequivalence study, the individual kinetic responses are evaluated from the measured concentrations. The means of the logarithmic responses of the two formulations are calculated.

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be …

Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities …

A bioequivalence assessment study is not as such an experimental study, but a form of data analysis and reporting form of a comparative bioavailability study. For a bioequivalence study, …

Bioequivalence is the study of different brands of a same drug and its dosage forms. When the rates of dissolution and absorption of two distinct formulations of the same drug are the same, …

A complete study report must be submitted for the bioequivalence study upon which the applicant relies for approval. For all other bioequivalence studies conducted on the same drug product …

A bioequivalence study is a type of pharmaceutical research that compares the pharmacokinetic and pharmacodynamic properties of two drug formulations to determine if they are essentially …

Generic drug companies gained greater access to the market for prescription drugs, and brand-name companies gained restoration of patent life of their products lost during the FDA’s …

2010年1月29日 · This guidance specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.