CPSA Shanghai 2012
From Bench to Decision Making - From Basics to Application
April 25 - 27, 2012
Renaissance Shanghai Pudong Hotel
Shanghai, China
Abstract
Wednesday
Regulated LC-MS Bioanalysis Workshop
Workshop Leaders: Wenkui Li, Novartis; Naidong Weng, Johnson & Johnson
Instructors:
Wenkui Li, Novartis
Wenying Jian, Johnson & Johnson
Naidong Weng, Johnson & Johnson
Fengying Chen, WuXi AppTec
Robert Coldreck, WuXi AppTec
Bioanalysis using liquid chromatography in combination with mass spectrometry (LC-MS), employed for the quantitative determination of drugs, their metabolites, and biomarkers in various biological fluids, plays a significant role in the evaluation and result interpretation of toxicokinetic (TK), pharmacokinetic (PK), bioavailability (BA), and/or bioequivalence (BE) studies as well as post-approval therapeutic drug monitoring (TDM). The quality of these studies, which are often used to support regulatory filings and other evaluations, is directly related to the conduct of the underlying bioanalysis. It is therefore important that bioanalytical scientists and executives in the field have an adequate understanding of the current international regulations related to LC-MS bioanalytical assays as well as sound scientific strategies for method development, validation, sample analysis, day-to-day documentation and data management. This workshop is designed for both novice and experienced bioanalytical professionals.
The workshop will provide updated perspectives on the following important topics of regulated LC-MS bioanalysis:
- Overview of GLP principles and key elements of a regulated bioanalytical laboratory
- Technical considerations for bioanalytical method development, validation, sample analysis, and incurred sample reanalysis
- Strategies in LC-MS bioanalysis of unstable small molecules
- Special considerations for LC-MS bioanalysis of proteins and peptides
- Challenges and solutions for LC-MS analysis of biomarkers
- Practical considerations and preparations for bioanalytical laboratory audit and inspection
