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.