Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations is
critical to efficient drug development. Traditionally, in vitro evaluation of oral drug …

The availability of in vitro tools that are constructed on the basis of a detailed knowledge of
key aspects of gastrointestinal (GI) physiology and their impact on formulation performance …

Objectives To summarize the basis for and progress with the development of in-vitro–in-
silico–in-vivo (IV-IS-IV) relationships for oral dosage forms using physiologically based …

The application of in silico modeling to predict the in vivo outcome of an oral drug product is
gaining a lot of interest. Fully relying on these models as a surrogate tool requires …

Dissolution tests that can predict the in vivo performance of drug products are usually called
biorelevant dissolution tests. Biorelevant dissolution testing can be used to guide …

For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution
and absorption. In the context of drug product quality, safe space is defined as the …

In vitro dissolution experiments are used to qualitatively assess the impact of formulation
composition and process changes on the drug dosage form performance. However, the use …

Although several routes of administration can be considered for new drug entities, the most
popular remains the oral route. To predict the in vivo performance of a drug after oral …

Abstract The Biopharmaceutics Classification System (BCS) has found widespread utility in
drug discovery, product development and drug product regulatory sciences. The …

A key goal in pharmaceutical development of dosage forms is a good understanding of the
in vitro and in vivo performance of the dosage forms. One of the challenges of …