Related Experiment Video
Updated: May 14, 2026

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
Published on: July 14, 2023
Strategic regulatory approaches for the qualification of a biomarker assay for safety use
Anna P Valeri1, Michelle Beharry, David R Jones
1Medicines & Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK.
Abstract:
Biomarkers can be defined as key molecular or cellular events that link a specific biological event to a health outcome. As such, biomarkers play an important role in understanding the relationships between exposure to a xenobiotic, the development of chronic human diseases, and the identification of subgroups that are at increased risk of disease. Much progress has been made in identifying and validating new biomarkers to be used in population-based studies. The increasing availability and use of biomarkers to aid informed decision-making in risk-benefit decisions highlights the need for careful assessment of the validity of such models. In particular, models involving new biomarkers require careful validation and regulatory acceptance.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Drug Products: Biologics, Biosimilars and Interchangeables
Drug Regulation
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
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...
