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 …

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,...

Oct 23, 2025 · Bioequivalence requires that two drugs release the active ingredient into the bloodstream in the same dose, at the same absorption rate, and with the same quality. The …

Based on pharmacokinetic (PK) data collected, bioequivalence can then be assessed using valid statistical methods according to some pre-specified regulatory criteria for bioequivalence. As …

What is bioequivalence? Learn how it supports the development of safe, effective generic drug products and regulatory approval.

The concept of bioequivalence ensures that generic drugs can be substituted for branded drugs without compromising efficacy or safety. This principle is based on the assumption that if two …

Aug 14, 2025 · Bioequivalence means that the generic drug releases its active ingredient into the body at the same rate and extent as the brand-name drug, ensuring that patients receive the …