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

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses01:25

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

392
A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...
392
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

372
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
372
Dosage Regimen: Multiple Oral Dosage01:25

Dosage Regimen: Multiple Oral Dosage

491
Understanding how a drug's concentration fluctuates within the body over time is crucial in pharmacokinetics, particularly with multiple oral doses. A graphical representation of multiple oral dosages provides insight into these dynamics. Typical accumulation curves of a drug's concentration in the body reveal a sawtooth pattern, indicating periodic peaks and troughs correlating with each dose administration and the drug's subsequent elimination.The plasma concentration at any time during an...
491
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.6K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K
Dose Size and Dosing Frequency: Determination Methods01:21

Dose Size and Dosing Frequency: Determination Methods

770
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...
770
Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

2.3K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
2.3K

You might also read

Related Articles

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

Sort by
Same author

Bayesian Methods for Subgroup Efficacy and Safety: Application to Japanese Patients in JAVELIN Renal 101.

JCO clinical cancer informatics·2026
Same author

Bayesian Analysis to Refine East Asian Subgroup Estimates in the CLEAR Trial (Lenvatinib Plus Pembrolizumab <i>vs</i>. Sunitinib) for Advanced Renal Cell Carcinoma.

Anticancer research·2026
Same author

Comparison of the effects of low-irradiance and high-irradiance phototherapy on non-hemolytic neonatal jaundice.

Scientific reports·2026
Same author

Auditory Involvement in Inflammatory Bowel Disease: Clinical Predictors and Prognostic Implications.

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·2026
Same author

Adjunctive posterior wall isolation for persistent and long-standing persistent atrial fibrillation: the CORNERSTONE AF trial.

European heart journal·2026
Same author

Bayesian re-analysis of ERA223 and PEACE-3 temporal dynamics and bone protection in radium-223-treated metastatic castration-resistant prostate cancer.

Japanese journal of clinical oncology·2026
Same journal

Correction.

Journal of biopharmaceutical statistics·2026
Same journal

Leveraging external controls in clinical trials: estimands, estimation, assumptions.

Journal of biopharmaceutical statistics·2026
Same journal

Special issue of nonclinical statistics in regulatory applications guest editors' notes.

Journal of biopharmaceutical statistics·2026
Same journal

Comparison of flexible parametric modeling and nonparametric methods to estimate restricted mean survival time: A simulation study.

Journal of biopharmaceutical statistics·2026
Same journal

Simulated treatment comparisons with jackknife pseudo values for estimating population-adjusted marginal treatment effects.

Journal of biopharmaceutical statistics·2026
Same journal

Sample sizes for randomized controlled trials utilizing Bayesian response adaptive randomization for continuous outcomes.

Journal of biopharmaceutical statistics·2026
See all related articles

Related Experiment Video

Updated: Apr 21, 2026

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

11.8K

A Dose-Finding Method Based on Multiple Dosing in Two-Agent Combination Phase I Trials.

Yasuyuki Kakurai1, Akihiro Hirakawa, Chikuma Hamada

  • 1a Department of Management Science, Graduate School of Engineering , Tokyo University of Science , Tokyo , Japan.

Journal of Biopharmaceutical Statistics
|November 6, 2014
PubMed
Summary
This summary is machine-generated.

This study introduces a novel dose-finding method for two-agent combination Phase I trials. The new approach partitions patients into cohorts based on multiple dose combinations, improving upon existing single-dose allocation strategies.

Keywords:
CombinationDose-finding studiesMultiple dosingPhase I trials

More Related Videos

Diagonal Method to Measure Synergy Among Any Number of Drugs
12:08

Diagonal Method to Measure Synergy Among Any Number of Drugs

Published on: June 21, 2018

21.0K
Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice
08:57

Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice

Published on: October 5, 2017

9.8K

Related Experiment Videos

Last Updated: Apr 21, 2026

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

11.8K
Diagonal Method to Measure Synergy Among Any Number of Drugs
12:08

Diagonal Method to Measure Synergy Among Any Number of Drugs

Published on: June 21, 2018

21.0K
Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice
08:57

Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice

Published on: October 5, 2017

9.8K

Area of Science:

  • Clinical Trials Methodology
  • Pharmacometrics
  • Drug Development

Background:

  • Phase I clinical trials are crucial for determining safe and effective drug dosages.
  • Two-agent combination therapies require complex dose-finding strategies.
  • Existing methods often allocate patients to single dose combinations within a cohort.

Purpose of the Study:

  • To develop and evaluate a novel dose-finding method for two-agent combination Phase I trials.
  • To improve patient cohort partitioning based on acceptable toxicity ranges.
  • To compare the performance of the new method against existing approaches.

Main Methods:

  • Developed a new dose-finding method partitioning patient cohorts by multiple dose combinations.
  • Defined cohorts based on a prespecified acceptable toxicity range.
  • Conducted simulation studies to compare operating characteristics.

Main Results:

  • The proposed method allows for partitioning patients within a cohort into multiple dose combinations.
  • Simulation studies demonstrated the operating characteristics of the new method.
  • Comparison with existing methods is detailed.

Conclusions:

  • The novel dose-finding method offers a flexible approach for Phase I combination trials.
  • This partitioning strategy enhances dose-finding precision in complex therapeutic settings.
  • Further evaluation is warranted to confirm clinical utility.