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 directs individual judgement in validation. Specific validation testing including stock stability, whole blood stability, and recovery is inconsistently performed and the merits of these tests is 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 validation of hybrid LC-MS/MS assays and discuss aspects of testing that remain poorly defined.
Topics for discussion will include:
- What modifications to hybrid LC-MS/MS assays are needed due to 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.
This webinar is being hosted by Bioanalysis Zone. Please follow the link below to register for the event on their website.
Speakers:
Megan Cooley
Megan’s field of expertise includes LC-MS and LC and CE with electrochemical detection. She 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. Megan holds a Doctorate degree in Bioanalytical Chemistry from the University of Kansas.
Audience:
- Scientists involved in PK studies
- Bioanalytical scientists
- Those interested in ICH M10