Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Data Validation01:15

Data Validation

235
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
235

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Characterization of Urinary Kidney Injury Biomarker Profiles in Healthy Japanese Subjects With Reference to a Counterpart US Study.

Clinical and translational science·2026
Same author

Immunogenicity assays are biomarker assays: is the 3-tiered paradigm fit-for-purpose? An illustrative case study.

Bioanalysis·2026
Same author

From tiers to truth - a biomarker-based framework for clinically relevant immunogenicity assessment.

Bioanalysis·2026
Same author

Rethinking immunogenicity: an integrated approach reveals the PK/PD impact of pre-existing and drug-sustaining ADA.

Bioanalysis·2026
Same author

Progress and promise of pharmacodynamic biomarkers: novel strategies and assay considerations in drug development.

Bioanalysis·2026
Same author

Best practices in the application of parallelism for biomarker assay validation.

The AAPS journal·2026

Related Experiment Video

Updated: Sep 11, 2025

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

2.4K

Special consideration: commentary on the 2025 FDA Bioanalytical Method Validation for Biomarkers

Karen J Quadrini1, Jiri Aubrecht1, Nicholas M P King2

  • 1Clinical Biomarkers, Prothena Biosciences, Inc, Brisbane, CA, USA.

Bioanalysis
|August 12, 2025
PubMed
Summary

No abstract available in PubMed .

Keywords:
Biomarkersclinicalmethod developmentregulatoryvalidation

More Related Videos

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

5.1K
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

17.8K

Related Experiment Videos

Last Updated: Sep 11, 2025

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

2.4K
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

5.1K
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

17.8K