Chemical Inventory Management System (CIMS) is a custom-developed application by Alturas that has evolved from a small database for tracking of a few basic reagents to a system that currently functions as an electronic...
Bioanalysis of oligonucleotides by HPLC-MS/MS in support of regulatory submission has not been widely adopted. Several obstacles such as lack of sensitivity, adduct formation and analytical instrument dedication are barriers...
About the Presenter
Jason Watts, Ph.D., is a scientist at Alturas Analytics Inc. focusing on HPLC-MS/MS techniques for method development, validation, and sample analysis of new chemical entities and biomolecules utilizing...
About the Presenter
Dr. Jennifer Zimmer is the Laboratory Director at Alturas Analytics, Inc. and has been working in the field of bioanalysis for over 20 years. She received her B.A. degree in English and...
With the recent adoption of the ICH M10 guidelines, the discussion shifts to the implementation of this latest technical document (Step 5). The ICH M10 provides recommendations on how to validate a bioanalytical assay for drug...
The adoption of ICH M10 will introduce several operational changes in the regulated bioanalytical laboratory. While most of these changes are minor, depending upon the stage of development for a drug discovery program, they...
