Related Experiment Video
Updated: Jan 16, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Use of Biomarkers in Drug Development for Regulatory Purposes
Robert N Schuck1, Vanitha Sekar2
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
None:
Appropriately validated biomarkers are important tools that can benefit drug development and regulatory assessments. For drug development purposes, biomarker development involves identifying a drug development need and context of use (COU) for the biomarker, analytically validating assays, clinically validating the biomarker for the COU, and determining if the biomarker provides benefits over current methods. This perspective provides information on determining a biomarker's COU, fit-for-purpose validation, and regulatory acceptance of biomarkers for drug development.
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Drug Regulation
Preclinical Development: Overview
Measurement of Bioavailability: Pharmacodynamic Methods
Clinical Trials: Overview
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

