Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs

Various approaches for evaluating the bioequivalence (BE) of highly variable drugs (CV ≥ 30%) have been debated for many years. More recently, the FDA conducted research to evaluate one such appro...

Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case...

Design and Evaluation of Thioalkylated Mannose-Modified Dendrimer (G3)/α-Cyclodextrin Conjugates as Antigen-Presenting Cell-Selective siRNA Carriers

The online version of this article (doi:10.1208/s12248-014-9665-9) contains supplementary material, which is available to authorized users.

A semiautomated approach to gene discovery through expressed sequence tag data mining: Discovery of new human transporter genes

Identification and functional characterization of the genes in the human genome remain a major challenge. A principal source of publicly available information used for this purpose is the National Center for Biotechnolog...