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

Response Surface Methodology01:16

Response Surface Methodology

710
Response Surface Methodology (RSM) is a collection of statistical and mathematical techniques used to develop, improve, and optimize processes. It is particularly valuable when many input variables or factors potentially influence a response variable.
The process of RSM involves several key steps:
710
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

500
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,...
500
Pharmacodynamic Models: Direct Effect Model and Indirect Response Model01:29

Pharmacodynamic Models: Direct Effect Model and Indirect Response Model

43
Pharmacodynamic models are essential tools in understanding the relationship between drug concentrations and their effects on biological systems. By characterizing the dynamics of drug action, these models guide dose selection, optimize therapeutic efficacy, and inform the development of new drugs. Two major classes of pharmacodynamic models include direct effect and indirect response models.Direct Effect ModelsDirect effect models describe the immediate relationship between drug concentration...
43
Pharmacodynamic Models: Additive and Proportional Drug Effect Model01:09

Pharmacodynamic Models: Additive and Proportional Drug Effect Model

37
Drug response models describe how pharmacological agents interact with biological systems to produce measurable effects. Baseline responses are inherent physiological activities without a drug significantly influencing the observed pharmacological outcomes. Depending on the drug response model employed, these baseline responses may combine with the drug's effect in either an additive or proportional manner.Additive Drug Response ModelIn the additive model, the drug effect is independent of the...
37
Genome-wide Association Studies-GWAS01:11

Genome-wide Association Studies-GWAS

15.9K
Genome-wide association studies or GWAS are used to identify whether common SNPs are associated with certain diseases. Suppose specific SNPs are more frequently observed in individuals with a particular disease than those without the disease. In that case, those SNPs are said to be associated with the disease. Chi-square analysis is performed to check the probability of the allele likely to be associated with the disease.
GWAS does not require the identification of the target gene involved in...
15.9K

You might also read

Related Articles

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

Sort by
Same author

Food and Drug Administration regulation of biosimilar products: Improving affordability of biologics for patients with asthma and allergic diseases.

The Journal of allergy and clinical immunology·2026
Same author

Approval of Upadacitinib in Pediatric Patients with Active Polyarticular Juvenile Idiopathic Arthritis or Active Psoriatic Arthritis: A Regulatory Perspective.

Journal of clinical pharmacology·2025
Same author

Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products.

The AAPS journal·2025
Same author

Comparison of Analysis of Covariance and Analysis of Variance in Pharmacokinetic Similarity Studies.

Journal of clinical pharmacology·2025
Same author

Model-Informed Drug Development-Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non-Radiographic Axial Spondyloarthritis.

Clinical pharmacology and therapeutics·2024
Same author

Evaluation of Truncated AUC as an Alternative Measure to Assess Pharmacokinetic Comparability in Bridging Biologic-Device Using Prefilled Syringes and Autoinjectors.

Journal of clinical pharmacology·2023

Related Experiment Video

Updated: Feb 24, 2026

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice
07:37

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice

Published on: June 6, 2025

1.3K

Exposure-Response Modeling and Power Analysis of Components of ACR Response Criteria in Rheumatoid Arthritis (Part 2:

Liang Li1, Yi Zhang1,2, Lian Ma3

  • 1Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Journal of Clinical Pharmacology
|August 18, 2017
PubMed
Summary

Population pharmacokinetic/pharmacodynamic (PK/PD) models reveal that swollen joint count (SJC) and tender joint count (TJC) are most sensitive for detecting rheumatoid arthritis treatment effects. Continuous and binary measures showed similar sensitivity for treatment differences.

Keywords:
American College of Rheumatology (ACR)continuous outcomeexposure-responsemodeling and simulationpower analysisrheumatoid arthritis (RA)

More Related Videos

Author Spotlight: Implementation of BIVA for Analyzing Disease Risk Factors in Patients with Low Body Cell Mass
07:44

Author Spotlight: Implementation of BIVA for Analyzing Disease Risk Factors in Patients with Low Body Cell Mass

Published on: July 14, 2023

1.7K
Author Spotlight: Enhancing Rheumatoid Arthritis Research Through HR-pQCT Imaging Analysis
06:31

Author Spotlight: Enhancing Rheumatoid Arthritis Research Through HR-pQCT Imaging Analysis

Published on: October 6, 2023

3.2K

Related Experiment Videos

Last Updated: Feb 24, 2026

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice
07:37

An Adoptive Transfer Model of Rheumatoid Arthritis in Mice

Published on: June 6, 2025

1.3K
Author Spotlight: Implementation of BIVA for Analyzing Disease Risk Factors in Patients with Low Body Cell Mass
07:44

Author Spotlight: Implementation of BIVA for Analyzing Disease Risk Factors in Patients with Low Body Cell Mass

Published on: July 14, 2023

1.7K
Author Spotlight: Enhancing Rheumatoid Arthritis Research Through HR-pQCT Imaging Analysis
06:31

Author Spotlight: Enhancing Rheumatoid Arthritis Research Through HR-pQCT Imaging Analysis

Published on: October 6, 2023

3.2K

Area of Science:

  • Pharmacometrics
  • Rheumatology
  • Clinical Pharmacology

Background:

  • Rheumatoid arthritis (RA) treatment efficacy is assessed using various American College of Rheumatology (ACR) subcomponents.
  • Understanding the relative sensitivity of these subcomponents is crucial for optimizing clinical trial design.

Purpose of the Study:

  • To develop population pharmacokinetic/pharmacodynamic (PK/PD) models for five RA biologics.
  • To quantify exposure-response relationships for ACR subcomponents.
  • To assess the relative sensitivity of ACR subcomponents in detecting treatment effects.

Main Methods:

  • Population PK/PD modeling using continuous longitudinal data for seven ACR subcomponents.
  • Simulation of clinical outcomes under different treatment regimens.
  • Monte Carlo simulation-based power analysis to evaluate subcomponent sensitivity.

Main Results:

  • Developed PK/PD models adequately described the relationship between serum concentrations and changes in ACR subcomponents.
  • Swollen joint count (SJC) and tender joint count (TJC) demonstrated higher sensitivity in detecting treatment effects compared to other ACR subcomponents.
  • Continuous and binary measures of ACR subcomponents exhibited similar power for detecting dose-dependent treatment differences.

Conclusions:

  • SJC and TJC are the most sensitive ACR subcomponents for detecting the efficacy of biologics in rheumatoid arthritis.
  • The choice between continuous or binary measures of ACR subcomponents may not significantly impact the power to detect treatment differences between doses.