Regulated Bioanalysis: Fundamentals and Practice

1. Introduction
Stephen Lowes, Mario L. Rocci

2. Understanding Bioanalysis Regulations
Mark Arnold, Eric Fluhler, Boris Gorovits

3. Logistical and Operational Practice in the Regulated Bioanalysis Laboratory
Patrick Bennett, Richard M. LeLacheur

4. Regulated Bioanalysis: Documentation and Reports
Surendra K. Bansal, Faye Vazvaei

5. Regulated Bioanalysis—Historical Aspects and Key Concepts Related to Its Use
Sheila Breidinger, Eric Woolf

6. Fundamentals of LC-MS/MS for Regulated Bioanalysis
Gary Schultz, Jack Henion

7. Liquid Chromatography–Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory
Stephanie S. Cape, Min Meng, Mohammad R. Koupaei-Abyazani, Douglas M. Fast

8. Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis
William Nowatzke, Franklin Spriggs, Van Fitzgerald, Aleks Davis, Ronald R. Bowsher

9. Ligand Binding Assays in the Regulated Bioanalytical Laboratory
Johanna Mora, Charles Hottenstein, Binodh DeSilva

Keywords: Biomedicine, Pharmaceutical Sciences/Technology