Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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...

You might also read

Related Articles

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

Sort by

Same author

Epitope mapping of humoral immunogenicity of orvacabtagene autoleucel shows an IgM response with minimal impact on CAR T cellular kinetics.

Molecular therapy. Advances·2026

Same author

Women in Pharmaceutical Sciences: Progress, Possibility, and Lasting Impact.

Pharmaceutical research·2026

Same author

Recruitment feasibility for deep brain stimulation compared to transcranial magnetic stimulation treatment trials for methamphetamine use disorder.

Addictive behaviors reports·2026

Same author

Stylet-driven vs non-stylet-driven leads for conduction system pacing: Insights from the NCDR Electrophysiology Device Implant Registry.

Heart rhythm·2026

Same author

Characterization of high energy, high average power, cryogenic laser amplifier head cooled using the reversed Brayton cycle.

The Review of scientific instruments·2026

Same author

A Rare Case of Chilaiditi Syndrome as a Driver of Chronic Respiratory Failure.

Respirology case reports·2026

Same journal

Whole-Body Pharmacokinetics of Ionizable Lipid, mRNA, and the Expressed Antibody following Intravenous Administration of mRNA-Loaded Lipid Nanoparticles.

The AAPS journal·2026

Same journal

Simple Hydrodynamic Molecular Weight Model for Rapid Assessment of Therapeutic Protein Oligomerization States in Formulation.

The AAPS journal·2026

Same journal

Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space.

The AAPS journal·2026

Same journal

Correction: Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation.

The AAPS journal·2026

Same journal

Quantitative Estimation of Clinical Intrasubject Variability of a Pharmacokinetic Parameter.

The AAPS journal·2026

Same journal

Targeting Pyruvate Kinase M2: Signal Transduction Pathways and Exploration of Cancer Therapeutic Strategies.

The AAPS journal·2026

See all related articles

Search research articles

Related Experiment Video

Updated: Jan 13, 2026

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

Anti-drug Antibody Validation Testing and Reporting Harmonization Addendum.

Heather Myler¹, Johanna Mora², Joao Pedras-Vasconcelos³

¹Translational Biomarkers and Bioanalytics, Takeda, Cambridge, Massachusetts, 02139, USA. heather.myler@takeda.com.

The AAPS Journal

|January 8, 2026

Summary

This summary is machine-generated.

This addendum refines anti-drug antibody (ADA) and neutralizing antibody (NAb) validation and reporting guidelines. It addresses user feedback, enhancing assay cross-validation, data presentation, and method sensitivity assessments for immunogenicity testing.

Keywords:

Anti-drug Antibodies (ADA)FDA immunogenicity regulatory guidance validation

More Related Videos

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Published on: January 17, 2018

High-Content Screening Assay for the Identification of Antibody-Dependent Cellular Cytotoxicity Modifying Compounds

High-Content Screening Assay for the Identification of Antibody-Dependent Cellular Cytotoxicity Modifying Compounds

Published on: August 18, 2023

Related Experiment Videos

Last Updated: Jan 13, 2026

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Simultaneous Distinction of Monospecific and Mixed DFS70 Patterns During ANA Screening with a Novel HEp-2 ELITE/DFS70 Knockout Substrate

Published on: January 17, 2018

High-Content Screening Assay for the Identification of Antibody-Dependent Cellular Cytotoxicity Modifying Compounds

High-Content Screening Assay for the Identification of Antibody-Dependent Cellular Cytotoxicity Modifying Compounds

Published on: August 18, 2023

Area of Science:

Bioanalytical science
Immunogenicity
Drug development

Background:

The anti-drug antibody (ADA) and neutralizing antibody (NAb) validation testing and reporting harmonization (ADAH and NAbH) white papers have garnered significant scientific interest.
User feedback highlighted gaps in the existing white papers, necessitating further clarification and updates.

Purpose of the Study:

To address identified gaps in ADA and NAb assay validation and reporting based on community feedback.
To provide updated guidance on assay cross-validation, data presentation for regulatory submissions, and method sensitivity assessments.
To incorporate recent discussions on the use of signal-to-noise ratios over titer in immunogenicity assessments.

Main Methods:

Solicitation and analysis of user feedback on previous white papers.
Development of an addendum to existing harmonization guidelines.
Inclusion of new sections on ADA assay cross-validation, ADA data presentation, and signal-to-noise ratio implementation.

Main Results:

An addendum has been developed to enhance the ADAH and NAbH white papers.
New guidance addresses critical areas such as ADA assay cross-validation and regulatory data presentation.
Updated method sensitivity assessments and a discussion on signal-to-noise ratio are included.

Conclusions:

The addendum provides crucial updates to harmonize anti-drug antibody and neutralizing antibody assay validation and reporting.
These revisions aim to further support the bioanalytical and immunogenicity communities in drug development.
The updated guidance facilitates consistent and accurate reporting for regulatory submissions.