The AAPS Journal - Themed Issue

Bioanalytical Method Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
Guest Editors: Mario L. Rocci, Jr., Vinod P. Shah, Mark J. Rose, and Jeffrey M. Sailstad

Table of Contents

Specificity and Selectivity Evaluations of Ligand Binding Assay of Protein Therapeutics Against Concomitant Drugs and Related Endogenous Proteins
Jean Lee, Hongjin Ma

Key Elements of Bioanalytical Method Validation for Small Molecules
Surendra Bansal, Anthony DeStefano

Workshop/Conference Report — Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
C. T. Viswanathan, Surendra Bansal, Brian Booth, Anthony J. DeStefano, Mark J. Rose, Jeffrey Sailstad, Vinod P. Shah, Jerome P. Skelly, Patrick G. Swann, and Russell Weiner

The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation
Vinod P. Shah

Best Practices During Bioanalytical Method Validation for the Characterization of Assay Reagents and the Evaluation of Analyte Stability in Assay Standards, Quality Controls, and Study Samples
William Nowatzke and Eric Woolf

Procedural Elements Involved in Maintaining Bioanalytical Data Integrity for Good Laboratory Practices Studies and Regulated Clinical Studies
Christopher A. James and Howard M. Hill

Critical Ligand Binding Reagent Preparation/Selection: When Specificity Depends on Reagents
Bonita Rup and Denise O’Hara

Key Elements of Bioanalytical Method Validation for Macromolecules
Marian Kelley and Binodh DeSilva

Appropriate Calibration Curve Fitting in Ligand Binding Assays
John W. A. Findlay and Robert F. Dillard