Application of a Physiologically Based Pharmacokinetic Model Informed by a Top-Down Approach for the Prediction of Pharmacokinetics in Chronic Kidney Disease Patients
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 5
Abstract
The online version of this article (doi:10.1208/s12248-014-9626-3) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Hiroyuki Sayama, Hiroaki Takubo, Hiroshi Komura, Motohiro Kogayu, Masahiro Iwaki
Keywords
Related Articles
- EP ID EP681669
- DOI 10.1208/s12248-014-9626-3
- Views 67
- Downloads 0
Evaluation of Pre-existing Antibody Presence as a Risk Factor for Posttreatment Anti-drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics
Biotherapeutic-reactive antibodies in treatment-naïve subjects (i.e., pre-existing antibodies) have been commonly detected during clinical immunogenicity assessments; however information on pre-existing antibody...
Statistical Power Calculations for Mixed Pharmacokinetic Study Designs Using a Population Approach
Simultaneous modelling of dense and sparse pharmacokinetic data is possible with a population approach. To determine the number of individuals required to detect the effect of a covariate, simulation-based power calculat...
Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies
This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis...
Transfection efficiency and toxicity of polyethylenimine in differentiated Calu-3 and nondifferentiated COS-1 cell cultures
In the present study, we evaluated polyethylenimine (PEI) of different molecular weights (MWs) as a DNA complexing agent for its efficiency in transfecting nondifferentiated COS-1 (green monkey fibroblasts) and well-diff...
Nonviral gene delivery: What we know and what is next
Gene delivery using nonviral approaches has been extensively studied as a basic tool for intracellular gene transfer and gene therapy. In the past, the primary focus has been on application of physical, chemical, and bio...