Blogs
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…
Blogs
Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies how…
Webinars
Join us Tuesday November 10, 2020 at 11am EST| 8am PST| 4pm CET| 5pm CET Bioanalytical liquid chromatography–mass spectrometry (LC–MS) for small molecules is often referred to as a routine technology. That perception may be true for many drugs, but as pharmaceutical companies move into new areas, more projects may…
Blogs
Dose Formulation Analysis is an essential step in regulated nonclinical studies to ensure correct doses are administered to underpin toxicokinetic assessments. Based on years of experience, KCAS has built a stand-alone team dedicated to…
Blogs
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…
Blogs
Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative to the known stability of…
Blogs
Surprisingly, there are a number of drug development companies that do not obtain stable isotope-labeled internal standards (SIL-IS) for their bioanalytical methods. Instead they settle for using a surrogate internal standard (a compound that closely resembles the measured analyte) which can lead to unreliable data and be detrimental to a…