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

For successful oral drug development, defining a bioequivalence (BE) safe space is critical
for the identification of newer bioequivalent formulations or for setting of clinically relevant in …

The recent impact of the Biopharmaceutics Classification System (BCS) and the
Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific …

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 …

This publication summarizes the proceedings of day 3 of a 3-day workshop on “Dissolution
and Translational Modeling Strategies Enabling Patient-Centric Product Development.” …

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 …

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 …

In line with the key focus of recent publications1-3 emerging from the labs of Dressman,
Amidon, and Shah, and in conjunction with the aims of both the FDA and US …

Abstract The Biopharmaceutics Classification System (BCS) categorizes drugs into one of
four biopharmaceutical classes according to their water solubility and membrane …

ABSTRACT The Biopharmaceutics Classification System (BCS) is a tool that was created to
categorize drugs into different groups according to their solubility and permeability …