Drug Product Performance: Bioavailability, Relative Bioavailability and Bioequivalence, 3rd Edition

Dear Colleagues,

In the third edition of this Special Issue, we continue our exploration of drug product performance regarding bioavailability, relative bioavailability, and bioequivalence.

In the first two volumes, we examined the challenges and opportunities associated with systemic absorption, highlighting the importance of in silico, in vitro, and in vivo methods for assessing bioavailability (BA) and bioequivalence (BE). We emphasized innovative tools and approaches, particularly the use of modelling techniques such as physiologically based biopharmaceutical models (PBBMs), which have significantly advanced our understanding of complex drug products.

In this third volume, we will further explore new methodologies and tools. We will focus on ER formulations, which require a refined understanding of the rate and extent of absorption as they often involve more complex release mechanisms compared to immediate-release dosage forms. This complexity adds value to the development of in vitro tools and the establishment of in vitro–in vivo correlations (IVIVCs). Assessment of their in vivo BA and BE may also demand more sophisticated considerations and additional pharmacokinetic parameters.

Moreover, ongoing initiatives within the International Council for Harmonisation (ICH) may lead to greater global harmonization in this area, and submissions addressing these developments are highly encouraged. We also welcome research employing advanced methodologies—including PBBM, population pharmacokinetic modelling, and the latest innovations in in vitro testing techniques—for all products requiring characterization of their BA or BE.

We invite researchers, drug developers, and regulators to submit original research articles and reviews that will contribute to advancing the knowledge of drug product performance.

Dr. Paulo Paixão
Guest Editor

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