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Related Concept Videos

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...
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...
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...
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...
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...
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,...

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Related Experiment Video

Updated: Jul 13, 2026

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Notes from the field: jumpstarting the IRB approval process in multicenter studies.

Jan Blustein1, Marsha Regenstein, Bruce Siegel

  • 1Wagner Graduate School, New York University, Puck Building, 295 Lafayette Street, New York, NY 10012, USA.

Health Services Research
|July 6, 2007
PubMed
Summary

Engaging hospitals early in planning for Institutional Review Board (IRB) review streamlines the process. Providing templates and using conference calls expedites multi-center study readiness.

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Last Updated: Jul 13, 2026

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
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Area of Science:

  • Clinical Research
  • Health Services Research
  • Regulatory Science

Background:

  • Multicenter studies require efficient Institutional Review Board (IRB) review.
  • Local IRB readiness can be a bottleneck in collaborative research.

Purpose of the Study:

  • To identify strategies for improving local IRB review readiness in multicenter studies.
  • To facilitate timely participation in quality improvement collaboratives.

Main Methods:

  • Case series design involving eleven acute care hospitals.
  • Data collection through participant observation and review of communications.
  • Focus on hospitals applying to a foundation-sponsored quality improvement collaborative.

Main Results:

  • Hospitals responded positively to early engagement in IRB planning.
  • Effective strategies included application templates, modular study descriptions, and conference calls.
  • These methods enabled early problem identification and timely IRB completion.

Conclusions:

  • Proactive engagement in IRB review planning expedites the process.
  • Facilitating IRB readiness does not compromise ethical review or fairness.
  • Early collaboration enhances multicenter study initiation.