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
Influence of Copolymer Composition on In Vitro and In Vivo Performance of Celecoxib-PVP/VA Amorphous Solid Dispersions
Previous studies suggested that an amorphous solid dispersion with a copolymer consisting of both hydrophobic and hydrophilic monomers could improve the dissolution profile of a poorly water-soluble drug compared to the...
A Quantitative Structure–Activity Relationship for Translocation of Tripeptides via the Human Proton-Coupled Peptide Transporter, hPEPT1 (SLC15A1)
The human intestinal proton-coupled peptide transporter, hPEPT1 (SLC15A1), has been identified as an absorptive transporter for both drug substances and prodrugs. An understanding of the prerequisites for transport has s...
Inactivation of hepatic enzymes by inhalant nitrite—In vivo and in vitro studies
We examined the effects of acute isobutyl nitrite (ISBN) exposure on the activity of several hepatic enzymes. Two strains of adult male mice (Balb/c and C57BL/6) were exposed to 900 ppm ISBN or ambient air for 45 minutes...
Physiologically Based Pharmacokinetic Predictions of Tramadol Exposure Throughout Pediatric Life: an Analysis of the Different Clearance Contributors with Emphasis on CYP2D6 Maturation
The online version of this article (doi:10.1208/s12248-015-9803-z) contains supplementary material, which is available to authorized users.
Predictive Models of Diffusive Nanoparticle Transport in 3-Dimensional Tumor Cell Spheroids
The rapidly evolving nanotechnology field highlights the need of better understanding the relationship between nanoparticle (NP) properties and NP transport in solid tumors. The present study tested the hypothesis that t...