
When you examine how to develop and validate/qualify a Biodistribution assay by PCR…

Produced by AAPS Organized by Sciex Recorded on December 6, 2023 eChalkTalk available here. Webinar Description: In this webinar, scientists from KCAS Bio, along with specialists from SCIEX Biopharma & Pharma Solutions discuss • Developing robust assays for PD biomarkers and their challenges…

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions(1). With the development of innovative and personalized therapies, biomarker tracking is increasingly important to support the clinical development…

With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…

Pharmacokinetic modeling during the drug development process is essential for determining whether an administered drug substance has the necessary characteristics to meet its intended medical use. Typically for small molecules, this is based on…