Futility Rules in Bioequivalence Trials with Sequential Designs
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 1
Abstract
The online version of this article (doi:10.1208/s12248-013-9540-0) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Anders Fuglsang
An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence
The online version of this article (doi:10.1208/s12248-016-9873-6) contains supplementary material, which is available to authorized users.
Model-based development of gemcabene, a new lipid-altering agent
The purpose of this study was to evaluate the value of model-based, quantitative decision making during the development of gemcabene, a novel lipid-altering agent. The decisions were driven by a model of the likely clini...
Enhancement of MHC-I Antigen Presentation via Architectural Control of pH-Responsive, Endosomolytic Polymer Nanoparticles
The online version of this article (doi:10.1208/s12248-014-9697-1) contains supplementary material, which is available to authorized users.
Evaluation of USP apparatus 3 for dissolution testing of immediate-release products
We sought to evaluate whether U.S. Pharmacopeia (USP) apparatus 3 can be used as an alternative to USP apparatus 2 for dissolution testing of immediate-release (IR) dosage forms. Highly soluble drugs, metoprolol and rani...
Coexistence of Passive and Proton Antiporter-Mediated Processes in Nicotine Transport at the Mouse Blood–Brain Barrier
Nicotine, the main tobacco alkaloid leading to smoking dependence, rapidly crosses the blood–brain barrier (BBB) to become concentrated in the brain. Recently, it has been shown that nicotine interacts with some...