Best practices for the validation of hybrid LC–MS/MS assays
Hybrid LC–MS/MS assays are not clearly defined in regulatory guidance like small molecule LC–MS/MS assays or ligand binding assays. Due to this lack of guidance, context of use in both primary and secondary matrices for hybrid assays direct individual judgement in validation. Specific validation testing including stock stability, whole blood stability and recovery is inconsistently performed and the merits of these tests are a point of debate between scientist performing traditional LC–MS/MS assays or ligand binding assays.
During this webinar we will discuss how ICH M10 has changed the validation of hybrid LC–MS/MS assays and discuss aspects of testing that remain poorly defined.
In this webinar we will address the following questions:
• What modifications to hybrid LC–MS/MS assays are needed due to the implementation of ICH M10
• Is stock stability necessary for validation and if so, how should this be performed
• Should whole blood stability be performed for hybrid assays and what does this test reveal
• Should recovery be performed and what are the implications for not doing it
• In tissue assays should recovery from tissue processing be performed as a part of validation or qualification
• Scientists involved in PK studies
• Bioanalytical scientists
• Those interested in ICH M10
Speaker
Megan Cooley
Associate Director of Bioanalytical Services
ICON (KS, USA)
Megan Cooley is Associate Director of Bioanalytical Services at ICON. Her field of expertise includes LC–MS and LC and CE with electrochemical detection. Megan has worked in the pharmaceutical industry as a bioanalytical scientist in clinical project teams for 7 years. She supports the LC–MS operational science teams in ICON’s laboratories located in Lenexa (KS, USA). Megan holds a Doctorate degree in Bioanalytical Chemistry from the University of Kansas (KS, USA)
In association with
This webinar was recorded on Thursday 30 November 2023.