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Related Concept Videos

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...
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...
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

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...
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
Methods of Documentation V: CBE01:23

Methods of Documentation V: CBE

Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...

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Related Experiment Video

Updated: Jun 8, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

A flexible approach to evidentiary standards for comparative effectiveness research.

Louis P Garrison1, Peter J Neumann, Paul Radensky

  • 1Department of Pharmacy, University of Washington, Seattle, USA. lgarrisn@u.washington.edu

Health Affairs (Project Hope)
|October 6, 2010
PubMed
Summary

The Patient-Centered Outcomes Research Institute should fund diverse study types to meet varied evidence needs. A flexible approach ensures public interest is best served by comparative effectiveness research.

Related Experiment Videos

Last Updated: Jun 8, 2026

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits
08:27

Applying an eMASS Customization Program as a Research Tool to Evaluate Consumer Benefits

Published on: September 27, 2019

Area of Science:

  • Health Services Research
  • Comparative Effectiveness Research

Background:

  • The Patient Protection and Affordable Care Act created the Patient-Centered Outcomes Research Institute (PCORI).
  • PCORI is tasked with identifying research priorities and developing standards for comparative effectiveness research.
  • Diverse stakeholders, including government agencies, providers, and patients, utilize different standards for evidence.

Purpose of the Study:

  • To examine how PCORI can accommodate the varying evidence standards of different decision-making groups.
  • To propose a framework for PCORI to support diverse evidence needs.

Main Methods:

  • The paper analyzes the roles and evidence requirements of various stakeholders in healthcare.
  • It considers the implications of different study designs and evidence types for PCORI funding decisions.

Main Results:

  • Different decision-makers rely on distinct types of evidence to inform their choices.
  • A one-size-fits-all approach to evidence standards may not adequately serve the public interest.

Conclusions:

  • PCORI should adopt a balanced and flexible strategy for funding comparative effectiveness research.
  • This approach will ensure that research findings are relevant and applicable to a wide range of stakeholders.