Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 3
Abstract
The online version of this article (doi:10.1208/s12248-015-9744-6) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Anders Fuglsang
Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA
The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Esse...
Combined Use of In Vitro Phototoxic Assessments and Cassette Dosing Pharmacokinetic Study for Phototoxicity Characterization of Fluoroquinolones
The present study aimed to develop an effective screening strategy to predict in vivo phototoxicity of multiple compounds by combined use of in vitro phototoxicity assessments and cassette dosing pharmacokinetic (PK) stu...
Effects of Selected OATP and/or ABC Transporter Inhibitors on the Brain and Whole-Body Distribution of Glyburide
Glyburide (glibenclamide, GLB) is a widely prescribed antidiabetic with potential beneficial effects in central nervous system injury and diseases. In vitro studies show that GLB is a substrate of organic anion transport...
RGS6 as a Novel Therapeutic Target in CNS Diseases and Cancer
Regulator of G protein signaling (RGS) proteins are gatekeepers regulating the cellular responses induced by G protein-coupled receptor (GPCR)-mediated activation of heterotrimeric G proteins. Specifically, RGS proteins...
Preformulation development of recombinant pegylated staphylokinase SY161 using statistical design
The goal of this study was to perform preformulation development of SY161 by using statistical design methods to understand the effects of buffer strength, NaCl concentration, and pH on conformation and stability of the...