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

Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

402
Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
402
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

307
Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
307
Dosage Regimen Designs: Nomograms and Tabulations01:23

Dosage Regimen Designs: Nomograms and Tabulations

264
Nomograms and tabulations are vital tools used by clinicians to design accurate and individualized dosage regimens. These instruments provide a straightforward method for adjusting dosages based on individual patient characteristics, including age, weight, and physiological condition. The foundation of a drug's nomogram is population pharmacokinetic data collected and analyzed using specific models. This data simplifies complex equations, presenting them diagrammatically or tabularly for easy...
264
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

338
Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
338
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models01:06

Model Approaches for Pharmacokinetic Data: Distributed Parameter Models

299
Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
299
Dose Size and Dosing Frequency: Determination Methods01:21

Dose Size and Dosing Frequency: Determination Methods

432
Determining the optimal dose size and dosing frequency in pharmacotherapy is crucial for achieving therapeutic effectiveness while minimizing adverse effects. This article explores the methodologies employed in determining these parameters, focusing on their significance and interplay to tailor dosing regimens.Dose Size: Dose size refers to the amount of a drug administered in a single dose. It is determined based on the drug's pharmacodynamics and pharmacokinetics properties and...
432

You might also read

Related Articles

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

Sort by
Same author

Barriers and facilitators to intracerebral haemorrhage platform trial recruitment: a survey of stroke clinicians.

Cerebrovascular diseases (Basel, Switzerland)·2026
Same author

Alpha2 agonists for sedation to produce better outcomes for adults with critical illness: a synopsis of the A2B RCT with cost-effectiveness and process evaluation.

Health technology assessment (Winchester, England)·2026
Same author

Will the Pharmaceutical Industry Need Statisticians in an AI World?

Pharmaceutical statistics·2026
Same author

Optimising patient centred drug development to realise impact.

Communications medicine·2026
Same author

A Phase I trial of the anti-IL23 monoclonal antibody tildrakizumab, in combination with abiraterone acetate, for the treatment of metastatic castration-resistant prostate cancer.

Investigational new drugs·2026
Same author

Teriparatide Plus Zoledronic Acid for Osteogenesis Imperfecta: A Randomized Clinical Trial.

JAMA·2026

Related Experiment Video

Updated: Feb 27, 2026

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
20:24

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study

Published on: January 31, 2014

17.2K

Embracing model-based designs for dose-finding trials.

Sharon B Love1, Sarah Brown2, Christopher J Weir3

  • 1Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, NDORMS, University of Oxford, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, UK.

British Journal of Cancer
|July 1, 2017
PubMed
Summary
This summary is machine-generated.

Model-based designs like the continual reassessment method (CRM) offer superior dose-finding in drug development. Overcoming barriers in academia can enhance trial efficiency and success.

More Related Videos

Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow
08:58

Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow

Published on: October 17, 2025

740
Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform
07:57

Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform

Published on: March 24, 2022

3.3K

Related Experiment Videos

Last Updated: Feb 27, 2026

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
20:24

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study

Published on: January 31, 2014

17.2K
Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow
08:58

Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow

Published on: October 17, 2025

740
Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform
07:57

Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform

Published on: March 24, 2022

3.3K

Area of Science:

  • Clinical Drug Development
  • Biostatistics
  • Pharmaceutical Research

Background:

  • Dose-finding trials are critical for establishing safe and effective drug dosages.
  • Model-based designs, such as the continual reassessment method (CRM), offer advantages over traditional methods.
  • Wider adoption of advanced dose-finding methodologies is needed in clinical research.

Purpose of the Study:

  • To advocate for increased utilization of model-based designs in dose-finding studies.
  • To identify and address barriers hindering the implementation of model-based designs in academic settings.
  • To provide recommendations for enhancing the adoption of these advanced trial designs.

Main Methods:

  • A comprehensive literature review of existing dose-finding designs was conducted.
  • A survey was administered to identify perceived obstacles to implementing model-based designs.
  • A real-world case study was used to demonstrate practical solutions to implementation challenges.

Main Results:

  • Model-based designs provide flexibility, improved operating characteristics, and broader applicability.
  • Key barriers include insufficient training, preference for traditional designs (e.g., 3+3), and limited upfront resources.
  • Industry leaders routinely employ model-based designs, highlighting their proven benefits.

Conclusions:

  • The benefits of the continual reassessment method (CRM) are well-established.
  • Barriers exist for academic statisticians and clinical researchers in adopting model-based designs.
  • Collaborative support from funders, regulators, and journals can accelerate progress in dose-finding trial design and drug development.