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

535
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:
535
Development of Analytical Methods01:21

Development of Analytical Methods

1.6K
An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
1.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

373
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
373
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

171
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
171
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

191
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
191

You might also read

Related Articles

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

Sort by
Same author

Stigmatising Attitudes Towards People With Depression, Bipolar Disorder, Borderline Personality, ADHD and Early and Long-Term/Untreated Schizophrenia: Representative Survey of Australian Adults.

The Medical journal of Australia·2026
Same author

Experiences of discrimination and positive treatment among people who support a person with a mental health condition: a nationally representative survey.

Social psychiatry and psychiatric epidemiology·2026
Same author

A conserved dimerization element is required for protein kinase activation by <i>trans</i>-autophosphorylation.

bioRxiv : the preprint server for biology·2026
Same author

Mechanism of nucleolytic degradation of human ribosomes.

bioRxiv : the preprint server for biology·2026
Same author

The LARP1 RRM functions as a ribosome responsive regulator of TOP mRNAs.

bioRxiv : the preprint server for biology·2026
Same author

Nationally representative surveys of experiences of discrimination and positive treatment in people with mental health problems in Australia: Changes over 10 years.

Social science & medicine (1982)·2026
Same journal

A simple, sensitive microsample LC-MS assay for quercetin and isorhamnetin in mouse and human plasma: application to EMIQ treatment in myotonic dystrophy type 1.

Bioanalysis·2026
Same journal

ADA assays for high-dose biologics: redefining drug tolerance through clinical insights.

Bioanalysis·2026
Same journal

Comparison of SERS spectral data sets of blood serum samples of hypopharyngeal cancer using silver and gold nanoparticles as substrates.

Bioanalysis·2026
Same journal

The Gyrolab platform for immunogenicity assessment and biotherapeutic and biomarker analysis: technical advances and bioanalytical applications.

Bioanalysis·2026
Same journal

Simultaneous quantification of D-penicillamine, D-penicillamine disulfide, and L-cysteine-D-penicillamine disulfide in human plasma: optimization of sample preparation and mass spectrometry procedures to support bioequivalence studies.

Bioanalysis·2026
Same journal

Development and preliminary clinical application of a time-resolved fluoroimmunoassay for anti-rituximab antibodies in membranous nephropathy.

Bioanalysis·2026
See all related articles

Related Experiment Video

Updated: Jan 5, 2026

Multi-step Preparation Technique to Recover Multiple Metabolite Compound Classes for In-depth and Informative Metabolomic Analysis
11:25

Multi-step Preparation Technique to Recover Multiple Metabolite Compound Classes for In-depth and Informative Metabolomic Analysis

Published on: July 11, 2014

34.7K

Internal standards in regulated bioanalysis: putting in place a decision-making process during method development.

Michael J Wright1, Robert Wheller1, Geoff Wallace1

  • 1LGC Limited, Drug Development Solutions, Fordham, Cambridgeshire, CB7 5WW, UK.

Bioanalysis
|October 25, 2019
PubMed
Summary
This summary is machine-generated.

Selecting an appropriate internal standard (IS) is crucial for minimizing variability in bioanalytical assays. This perspective outlines key considerations and experiments for IS suitability assessment during method development to ensure assay reliability in drug studies.

Keywords:
internal standardliquid chromatography mass spectrometrymethod developmentmethod establishment

More Related Videos

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
04:50

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

1.6K
Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
09:04

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

17.5K

Related Experiment Videos

Last Updated: Jan 5, 2026

Multi-step Preparation Technique to Recover Multiple Metabolite Compound Classes for In-depth and Informative Metabolomic Analysis
11:25

Multi-step Preparation Technique to Recover Multiple Metabolite Compound Classes for In-depth and Informative Metabolomic Analysis

Published on: July 11, 2014

34.7K
Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
04:50

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

1.6K
Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
09:04

Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification

Published on: August 17, 2015

17.5K

Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics
  • Mass Spectrometry

Background:

  • Bioanalytical assays using liquid chromatography-mass spectrometry commonly employ internal standards (IS) to reduce variance.
  • Ensuring IS suitability is critical for regulated drug development studies.

Purpose of the Study:

  • To outline key considerations for selecting an internal standard (IS).
  • To propose experiments for demonstrating IS suitability during method development.
  • To present case studies illustrating challenges in internal standardization.

Main Methods:

  • Literature review and expert opinion on IS selection criteria.
  • Proposal of experimental designs for IS validation during method development.
  • Presentation of real-world case studies from laboratory observations.

Main Results:

  • Key factors for IS selection are identified.
  • A framework for early-stage IS suitability assessment is proposed.
  • Practical analytical challenges encountered in IS use are highlighted through case studies.

Conclusions:

  • Early and thorough evaluation of IS is essential for robust bioanalytical methods.
  • Demonstrating IS compensation for recovery, liquid handling, and ionization is vital prior to assay validation.
  • Understanding potential IS-related challenges improves assay reliability in drug development.