No Slide Title Page 1 Assessing the Similarity of Bioanalytical Methods Jason Liao, Ph.D. Merck
Research Laboratories Joint work with Yu Tian 2010 MBSW Page 2 2 Outline • Introduction • …

Bioanalytical methods, based on a variety of physico-chemical and biological techniques
such as chromatography, immunoassay and mass spectrometry, must be validated prior to …

For a number of years analytical chemists in the pharmaceutical and biomedical fields have
learned how to demonstrate that their methods have a performance that can guarantee …

Method validation has a long and productive history in the pharmaceutical and now,
biopharmaceutical industries, but it is an evolving discipline which changes with the times …

Workshop/Conference Report Bioanalytical Method Validation—A Revisit with a Decade of
Progress Page 1 Workshop/Conference Report Bioanalytical Method Validation—A Revisit with …

The concepts, importance, and application of bioanalytical method validation have been
discussed for a long time and validation of bioanalytical methods is widely accepted as …

In this work, the performance of the USP〈 1010〉 concept for comparing precision has been
investigated. A diagram has been constructed to relate common variance ratios, sample …

Results of a survey on method validation of analytical procedures used in the testing of drug
substances and finished products, of most major research based pharmaceutical companies …

138 LCGC NORTH AMERICA VOLUME 21 NUMBER 2 FEBRUARY 2003 www.
chromatographyonline. com centrations throughout the expected range. The guidelines also …

Bioanalysis is most widely used for drug discovery and development. Bioanalytical methods
have been working for the quantitative estimation of drugs, or its metabolites and biomarkers …