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

2.8K
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:
2.8K
Measurement of Bioavailability: Pharmacodynamic Methods01:20

Measurement of Bioavailability: Pharmacodynamic Methods

872
Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
872
Measurement of Bioavailability: Pharmacokinetic Methods01:30

Measurement of Bioavailability: Pharmacokinetic Methods

315
Pharmacokinetics is a vital branch of pharmacology that examines how drugs are absorbed, distributed, metabolized, and excreted by the body. Two key methodologies in pharmacokinetics are plasma drug concentration studies and urinary drug excretion analyses, both of which provide critical insights into a drug's therapeutic efficacy and bioavailability.Plasma Drug Concentration-Time StudiesPlasma drug concentration-time studies involve analyzing blood samples at specific intervals to quantify...
315

You might also read

Related Articles

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

Sort by
Same author

Epitope-selective vaccine designs to elicit protective antibodies against the Plasmodium falciparum circumsporozoite protein.

NPJ vaccines·2026
Same author

Mannosylated nanoparticle immunogens enhance the circumsporozoite protein-specific B cell response and improve protection against sporozoite challenge.

bioRxiv : the preprint server for biology·2026
Same author

Humoral Immune Correlates Analysis of Four Vaccines Against SARS-CoV-2 in Rhesus Macaques.

Research square·2026
Same author

Evaluation of clinical utility in emulated clinical trials.

European journal of epidemiology·2026
Same author

IgG and IgM responses to PfEMP1 domains associated with semi-immunity to clinical malaria in Burkinabe children under five.

Frontiers in immunology·2026
Same author

A stabilized tandem antigen chimera that elicits potent malaria transmission-reducing activity.

Nature communications·2026
Same journal

Predictor-Assisted Nonparametric Graphical Models With Multivariate Error-Prone Data.

Statistics in medicine·2026
Same journal

Optimizing Treatment Decision Estimation for Right-Censored Survival Data Through Parameter Transfer Learning.

Statistics in medicine·2026
Same journal

Latent Class Log-Linear Models for Estimating Diagnostic Test Accuracy Without a Gold Standard: A Simulation Study.

Statistics in medicine·2026
Same journal

Interpretable Bayesian Modeling for Multireader Multicase Studies: Addressing Overdispersion and Limited Sample Size in Diagnostic Enhancement Evaluation.

Statistics in medicine·2026
Same journal

Adaptive Sequential Multiple Hypotheses Testing for Concomitant Vaccine Safety Surveillance.

Statistics in medicine·2026
Same journal

Novel Distance Regression for Repeated Outcomes With Missing Data: Applications to Longitudinal and Crossover Studies of Microbiome Beta-Diversity.

Statistics in medicine·2026
See all related articles

Related Experiment Video

Updated: Feb 20, 2026

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

1.7K

Measuring precision in bioassays: Rethinking assay validation.

Michael P Fay1, Michael C Sachs2, Kazutoyo Miura3

  • 1Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Room 4B53, MSC 9820, Bethesda, MD 20892, USA.

Statistics in Medicine
|October 21, 2017
PubMed
Summary
This summary is machine-generated.

The m:n:θb procedure for assay validation has unknown statistical properties. This study reveals its passing probabilities and develops new confidence limits for precision assessment in bioassays.

Keywords:
assay qualificationcoefficient of variationfunctional assayrelative potency assaystandard deviation interval

More Related Videos

Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method
09:32

Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method

Published on: September 10, 2017

11.5K
Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader
09:15

Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader

Published on: July 27, 2022

2.7K

Related Experiment Videos

Last Updated: Feb 20, 2026

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

1.7K
Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method
09:32

Procedure and Key Optimization Strategies for an Automated Capillary Electrophoretic-based Immunoassay Method

Published on: September 10, 2017

11.5K
Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader
09:15

Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader

Published on: July 27, 2022

2.7K

Area of Science:

  • Biostatistics
  • Assay Development
  • Pharmacometrics

Background:

  • The m:n:θb procedure is a common method for validating assay precision.
  • Its statistical properties and performance under various conditions are not well understood.
  • Adaptation for relative potency assays with constant standard deviation (SD) models is unclear.

Purpose of the Study:

  • To investigate the statistical properties of the m:n:θb assay validation procedure.
  • To develop methods for precision assessment in assays, particularly for relative potency.
  • To provide statistically sound confidence intervals for assay outputs.

Main Methods:

  • Utilized simple normal error models to analyze assay precision.
  • Derived upper confidence limits for coefficient of variation (CV) under constant CV models.
  • Derived analogous confidence limits for SD under constant SD models.
  • Developed 68.27% confidence intervals for assay outputs under both models.

Main Results:

  • Under constant CV, passing probabilities when CV equals θb range from 10% to 20%.
  • When CV is heterogeneous and the largest CV is θb, passing probabilities can exceed 50%.
  • New confidence limits for CV and SD were derived, along with confidence intervals for assay outputs.

Conclusions:

  • The m:n:θb procedure's validation probabilities are highly dependent on the underlying error model and CV distribution.
  • The derived confidence limits offer a statistically rigorous approach to assay precision assessment.
  • The methods were successfully demonstrated on a malaria antibody growth inhibition assay.