Large Molecule Pharmacokinetic Assays For New Modalities
PK assays are a vital component of the drug development process and the data derived is utilized to help select the dosage for preclinical and clinical studies. Large molecule PK bioanalytical assays are generally analyzed using LBAs. Therapeutic monoclonal antibodies and proteins are well-known drug modalities but recently, new modalities have entered the drug development scene. In this webinar, case studies from different drug modalities will be presented with a focus on assay setup and the challenges and solutions for validating the assay.
What will you learn?
- The importance of PK assays in drug development
- How to setup and validate a PK assay
- Which assay platform should be considered for new drug modalities
Who may this interest?
- Bioanalytical scientists
- Clinical pharmacology operations
- Medical advisors
Speaker
Marianne Scheel Fjording
Scientific Officer, BioAgilytix (Copenhagen, Denmark)
Marianne Scheel Fjording has an extensive background in large molecule bioanalytical assay setup and assay validation, with more than 20 years of experience working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, she was Scientific Director at Novo Nordisk, where she delivered bioanalytical strategies for PK and biomarker assays. She is also a member of the Expert Working Group for ICH M10 Bioanalytical Method Development.
In association with
