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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...

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Related Experiment Video

Updated: Jul 16, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

[Introduction "why is it multinational clinical trial now?"].

Kazuhiko Mori1

  • 1Center for Product Review Pharmaceuticals Medical Devices Agency.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|February 16, 2007
PubMed
Summary

Japan faces significant anticancer drug lag, delaying patient access to innovations like oxaliplatin. This initiative aims to foster collaboration between industry, academia, and government to achieve simultaneous global drug development and overcome regulatory delays.

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Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
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Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay

Published on: September 16, 2012

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Last Updated: Jul 16, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
14:45

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay

Published on: September 16, 2012

Area of Science:

  • Oncology
  • Drug Development
  • Regulatory Science

Background:

  • Anticancer drug development faces significant delays in Japan compared to Western countries, impacting patient access to innovative therapies such as oxaliplatin.
  • The 'drug lag' phenomenon poses a serious challenge, necessitating urgent solutions to improve drug approval timelines.

Purpose of the Study:

  • To address the issue of drug lag in anticancer drug development in Japan.
  • To explore strategies for achieving simultaneous global development of anticancer drugs.
  • To foster collaboration among regulatory authorities, the pharmaceutical industry, academia, and government.

Main Methods:

  • Establishment of a collaborative forum involving industry, academia, and government stakeholders.
  • Discussion of clinical development strategies for anticancer drugs.
  • Exploration of multinational clinical trials involving Western and Asian countries.

Main Results:

  • Initiated a collaborative forum to discuss and address the drug lag problem.
  • Identified the need for a multi-angled approach to clinical development.
  • Explored the potential for simultaneous global development through international clinical trials.

Conclusions:

  • A collaborative approach involving multiple stakeholders is crucial to overcome drug lag.
  • Multinational clinical trials are essential for achieving simultaneous global drug development.
  • Japan aims to reduce its drug approval delay and integrate into global development timelines.