Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
Journal Title: The AAPS Journal - Year 2007, Vol 9, Issue 1
Abstract
For quantitative bioanalytical method validation procedure and requirements, there was a relatively good agreement between chromatographic assays and ligand-binding assays. It was realized that the quantitative and qualitative aspects of bioanalytical method validation should be reviewed and applied appropriately.
Authors and Affiliations
C. T. Viswanathan, Surendra Bansal, Brian Booth, Anthony J. DeStefano, Mark J. Rose, Jeffrey Sailstad, Vinod P. Shah, Jerome P. Skelly, Patrick G. Swann, Russell Weiner
Keywords
Related Articles
- EP ID EP681572
- DOI 10.1208/aapsj0901004
- Views 83
- Downloads 0
Improvement of Parameter Estimations in Tumor Growth Inhibition Models on Xenografted Animals: a Novel Method to Handle the Interval Censoring Caused by Measurement of Smaller Tumors
The online version of this article (doi:10.1208/s12248-015-9862-1) contains supplementary material, which is available to authorized users.
AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development
Therapeutic proteins (TPs) are increasingly combined with small molecules and/or with other TPs. However preclinical tools and in vitro test systems for assessing drug interaction potential of TPs such as monoclonal anti...
Mechanism-Based Pharmacokinetic Modeling to Evaluate Transporter-Enzyme Interplay in Drug Interactions and Pharmacogenetics of Glyburide
The purpose of this study is to characterize the involvement of hepato-biliary transport and cytochrome-P450 (CYP)-mediated metabolism in the disposition of glyburide and predict its pharmacokinetic variability due to dr...
Clinical Relevance of Dissolution Testing in Quality by Design
Quality by design (QbD) has recently been introduced in pharmaceutical product development in a regulatory context and the process of implementing such concepts in the drug approval process is presently on-going. This ha...
Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval
Dose–response analysis is one of the accepted efficacy endpoints to establish effectiveness. The purpose of this research was to inform selection of an appropriate pre-specified primary dose–response anal...