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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.1K
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...
10.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
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...
4.5K
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

143
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...
143
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

166
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...
166
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

387
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,...
387
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

136
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,...
136

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Related Experiment Video

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Comparing Two Food is Medicine Trials Using the RE-AIM Framework.

Bridget Simon-Friedt, Rachel G Tabak, Sylvester Tumusiime

    Medrxiv : the Preprint Server for Health Sciences
    |November 24, 2025
    PubMed
    Summary

    Food is Medicine (FIM) interventions show promise but face challenges with digital access and retail integration. Successful scaling requires hybrid models, strong partnerships, and sustainable funding for equitable healthcare.

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    Area of Science:

    • Public Health
    • Health Services Research
    • Health Equity

    Background:

    • Food is Medicine (FIM) interventions are increasingly integrated into healthcare.
    • Pilot studies were supported by the American Heart Association's Healthcare by Food initiative to test scalable FIM models.
    • This study compares two pilot FIM interventions: NutriConnect and Makin' Healthy Groceries.

    Purpose of the Study:

    • To compare two pilot Food is Medicine (FIM) interventions using the RE-AIM framework.
    • To identify cross-site lessons for FIM design, delivery, and implementation.
    • To inform future policy and practice for scalable FIM models.

    Main Methods:

    • Comparative analysis of two FIM trials: NutriConnect and Makin' Healthy Groceries.
    • Application of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance).
    • Examination of participant characteristics, intervention delivery, operational challenges, and contextual facilitators.

    Main Results:

    • Digital barriers (e.g., email redemption, digital literacy) constrained reach in both trials.
    • Retail system readiness impacted adoption, with tighter integration proving beneficial.
    • Implementation faced staff burden and customization needs, while maintenance highlighted cost and funding reliance.

    Conclusions:

    • FIM trial design and delivery are heterogeneous, requiring alignment with participant behaviors and retail systems.
    • Successful scale-up necessitates hybrid tech-human models, cross-sector partnerships, and sustainable reimbursement.
    • Pilot insights guide the development of equitable FIM implementation strategies.