A second volume in IVT's special edition series on Method Validation, this special edition seeks to solidfy and enhance the concepts from the previous special edition Analytical Method Validation. This special edition discusses analytical methods, appropiate documentation, FDA expectations, stability testing, and much more!
A Step-by-Step Approach to Establishing a Method Validation Program
Biological Method Validation A Practical Approach
Defining a Master Plan for the Validation of Analytical Methods
Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.
FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry
Jerry Lanese, Ph.D.
Guidance for Industry Bioanalytical Methods Validation for Human Studies
US Food and Drug Adminstration
Suitability of Analytical Methods for Stability Testing – Is There Room for Improvement?
David R. Rudd
Validation of Analytical Methodology: A Detailed Look at How to Assure the Quality of Your Data
Harry G. Brittain, Ph.D.