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

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

You might also read

Related Articles

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

Sort by
Same author

Pexidartinib impairs liver mitochondrial functions causing cell death in primary human hepatocytes at clinically relevant concentrations.

Biochemical and biophysical research communications·2025
Same author

Predicting oncology drug-induced cardiotoxicity with donor-specific iPSC-CMs-a proof-of-concept study with doxorubicin.

Toxicological sciences : an official journal of the Society of Toxicology·2024
Same author

Determination of structural factors affecting binding to mu, kappa and delta opioid receptors.

Archives of toxicology·2020
Same author

Comprehensive Identification and Characterization of Human Secretome Based on Integrative Proteomic and Transcriptomic Data.

Frontiers in cell and developmental biology·2019
Same author

Dr. Daniel Acosta and In Vitro toxicology at the U.S. Food and Drug Administration's National Center for Toxicological Research.

Toxicology in vitro : an international journal published in association with BIBRA·2019
Same author

The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.

Clinical and translational science·2019

Related Experiment Video

Updated: Jul 7, 2026

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
07:35

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Published on: October 11, 2018

Strategic paths for biomarker qualification.

Federico M Goodsaid1, Felix W Frueh, William Mattes

  • 1Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, FDA, MD 20903-0002, United States. Federico.Goodsaid@fda.hhs.gov

Toxicology
|February 19, 2008
PubMed
Summary

Biomarker qualification can be passive, relying on scientific literature consensus, or active, requiring a structured process. Active strategies are crucial for reaching consensus on biomarker qualification, considering both context-independent and context-dependent approaches.

More Related Videos

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
07:20

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Published on: January 28, 2014

Related Experiment Videos

Last Updated: Jul 7, 2026

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
07:35

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Published on: October 11, 2018

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
07:20

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Published on: January 28, 2014

Area of Science:

  • Biomarker research and development
  • Regulatory science
  • Translational medicine

Background:

  • Biomarker qualification is essential for clinical application.
  • Current methods for biomarker acceptance vary significantly.
  • A standardized approach is needed for reliable biomarker validation.

Purpose of the Study:

  • To explore different biomarker qualification processes.
  • To differentiate between passive and active qualification strategies.
  • To highlight the importance of consensus-building in biomarker validation.

Main Methods:

  • Literature review of existing biomarker qualification approaches.
  • Analysis of passive qualification methods (e.g., literature consensus).
  • Examination of active qualification strategies (context-independent and context-dependent).

Main Results:

  • Passive qualification relies on the acceptance of scientific literature.
  • Active qualification necessitates a defined process for consensus.
  • Both context-independent and context-dependent active strategies exist.

Conclusions:

  • Active biomarker qualification processes are superior for achieving consensus.
  • Structured approaches ensure robust and reproducible biomarker validation.
  • Further development of active qualification frameworks is recommended.