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

Data Validation

Data Validation

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:

Bioequivalence Data: Statistical Interpretation

Bioequivalence Data: Statistical Interpretation

The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...

You might also read

Related Articles

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

Sort by

Same author

A systematic approach to improve the initial success rates of bioanalytical assay transfers to contract research organizations.

Bioanalysis·2025

Same author

Visualizing and analyzing 3D biomolecular structures using Mol* at RCSB.org: Influenza A H5N1 virus proteome case study.

Protein science : a publication of the Protein Society·2025

Same author

Effect of E7777 Immunogenicity on Pharmacokinetics, Efficacy, and Safety in Adult Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.

Clinical and translational science·2025

Same author

A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.

Pharmaceutical research·2024

Same author

2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (<u>Part 2</u> - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).

Bioanalysis·2022

Same author

Biomarker Assay Validation by Mass Spectrometry.

The AAPS journal·2022

Search research articles

Related Experiment Video

Updated: Jun 6, 2026

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules.

Theingi M Thway¹, Chris R Macaraeg, Dominador Calamba

¹Department of Pharmacokinetics & Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. theingi.thway@amgen.com

|November 19, 2010

Summary

Incurred sample reanalysis (ISR) ensures bioanalytical method reproducibility for drug studies. This analysis of macromolecule therapeutics confirms ISR criteria are scientifically sound and reliable for method validation.

More Related Videos

PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis

PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis

Published on: May 11, 2017

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Published on: January 13, 2023

Related Experiment Videos

Last Updated: Jun 6, 2026

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis

PTR-ToF-MS Coupled with an Automated Sampling System and Tailored Data Analysis for Food Studies: Bioprocess Monitoring, Screening and Nose-space Analysis

Published on: May 11, 2017

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Microsampling in Targeted Mass Spectrometry-Based Protein Analysis of Low-Abundance Proteins

Published on: January 13, 2023

Area of Science:

Bioanalytical Chemistry
Pharmacokinetics
Drug Development

Background:

Regulatory agencies mandate Incurred Sample Reanalysis (ISR) for in-study validation.
ISR ensures the reproducibility of bioanalytical methods in pharmacokinetic/toxicokinetic and clinical studies.
This study presents five case studies focusing on macromolecule therapeutics.

Purpose of the Study:

To evaluate the efficacy and reliability of ISR acceptance criteria for macromolecule bioanalysis.
To assess the concordance between ISR criteria and the modified Bland-Altman approach.
To examine the impact of dilution factors on ISR results.

Main Methods:

Applied single ISR acceptance criteria (within 30% of original concentration).
Utilized a modified Bland-Altman (BA) approach to assess accuracy and precision.
Conducted simulation studies to compare ISR criteria and BA concordance.

Main Results:

All five methods successfully met the ISR criteria.
Thorough method development and pre-study validation are crucial for successful ISR.
The Bland-Altman analysis showed overall agreement within 20% between original and reanalyzed results.
Simulations indicated 95% concordance between ISR criteria and BA.
Dilution factors, even at 1:100 or higher, did not significantly impact ISR.

Conclusions:

Current ISR acceptance criteria for macromolecules are scientifically and statistically valid.
The criteria are meaningful for methods exhibiting a total error of 25% or less.
ISR is a robust validation parameter for bioanalytical methods supporting drug development.