Bioequivalence (BE) and bioavailability (BA) studies play a vital role in the drug development for both new drug products and their generic equivalents. BA and BE evaluation of formulations are components of new drug development.
Bioavailability is the concentration of the drug compound that reaches the systemic circulation or the site of action. Bioequivalence is used to assess the expected in vivo biological equivalence of a generic version to its proprietary version of a drug or formulations in different clinical trial phases. BA data provides an estimate of the fraction of the drug absorbed and the information related to the pharmacokinetics of the drug. When administered at the same molar dose, if the absorption degree and rate are not significantly different from those of reference products, then the drug is bioequivalent.
Fig. 1 Critical pathway for the development of a generic drug product (Mastan S, 2011)
BE & BA studies help industries towards the release of drug substances from their dosage form and its subsequent absorption in the circulation of therapeutic relevance. Our lab team is committed to developing and utilizing robust bioanalytical methods to assess drug bioavailability and bioequivalence. We regularly achieve Incurred Sample Reanalysis (ISR) requirements for bioequivalence studies to show reliability and reproducibility of data, as well as seek approval from regulatory agencies.
BOC Sciences perform regulated analysis for bioequivalence and bioavailability studies to accelerate the regulatory submission and drug approval applications such as IND, BLA, ANDA, and NDA.