This article summarizes historic developments, recent expert opinions, and (currently)
unresolved challenges concerning the Biopharmaceutics Classification System (BCS) …

This report summarizes podium presentations and breakout sessions from the second day of
the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of …

The establishment of an in vitro–in vivo correlation (IVIVC) is considered the gold standard
to establish in vivo relevance of a dissolution method and to utilize dissolution data in the …

Aims When administered orally as either an immediate or modified release dosage form,
zolpidem demonstrates a negative food effect, ie decrease in C max and AUC. The aim of …

This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of
enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference …

It has been revealed that buffer capacity of aspirated human intraluminal fluid is much lower
than that of in vitro compendial dissolution media. Since buffer capacity significantly alters …

This workshop report summarizes the proceedings of Day 1 of a three-day workshop on
“Current State and Future Expectations of Translational Modeling Strategies to Support Drug …

The purpose of the present study was to provide the experimental and theoretical basis of
bioequivalence (BE) dissolution test criteria for formulation development of high solubility …

Weakly basic drugs exhibit a pH-dependent dissolution profile in the gastrointestinal (GI)
tract, which makes it difficult to predict their oral absorption profile. The aim of this study was …

Abstract Model-informed drug discovery and development (MID3) shows great advantages
in facilitating drug development. A physiologically based pharmacokinetic model is one of …