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Related Concept Videos

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

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Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
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Dosage Regimen Designs: Nomograms and Tabulations01:23

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Nomograms and tabulations are vital tools used by clinicians to design accurate and individualized dosage regimens. These instruments provide a straightforward method for adjusting dosages based on individual patient characteristics, including age, weight, and physiological condition. The foundation of a drug's nomogram is population pharmacokinetic data collected and analyzed using specific models. This data simplifies complex equations, presenting them diagrammatically or tabularly for easy...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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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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One-Compartment Open Model for IV Bolus Administration: Estimation of Clearance00:56

One-Compartment Open Model for IV Bolus Administration: Estimation of Clearance

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Clearance is a key pharmacokinetic parameter that quantifies the volume of body fluid from which a drug is entirely removed within a specific time frame. It is crucial in assessing how a drug is eliminated from the body and has critical clinical applications.
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
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Bioequivalence studies: Biowaivers01:13

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Body: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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Nursing Clinical Information System01:27

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Nursing Clinical Information System (NCIS)
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Critical attributes of NCIS include:
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i2b2 to Optimize Patients Enrollment.

Mauro Bucalo1, Matteo Gabetta1, Lorenzo Chiudinelli2

  • 1BIOMERIS (BIOMEdical Research Informatics Solutions), Pavia, Italy.

Studies in Health Technology and Informatics
|May 27, 2021
PubMed
Summary
This summary is machine-generated.

The i2b2 data-warehouse effectively supports clinical trial enrollment by accurately identifying eligible patients. This tool demonstrated success in applying study criteria and increasing patient enrollment rates.

Keywords:
clinical data-warehousepatients enrollmentpatients recruitment

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Area of Science:

  • Health Informatics
  • Clinical Research Management
  • Data Warehousing

Background:

  • Clinical trial enrollment is a critical phase, often facing challenges with patient identification and recruitment.
  • Data-warehousing solutions offer potential for optimizing clinical trial processes.
  • The i2b2 platform is a widely used data-warehouse for clinical research.

Purpose of the Study:

  • To evaluate the performance of the i2b2 data-warehouse in supporting clinical trial enrollment.
  • To assess the efficacy of an i2b2 extension designed for suggesting eligible patients.

Main Methods:

  • The study involved evaluating the i2b2 data-warehouse on two distinct clinical trials.
  • An extension for the i2b2 platform was developed to aid in identifying potentially eligible patients.
  • Performance was measured by the ability to implement inclusion/exclusion criteria and the rate of patient enrollment.

Main Results:

  • The i2b2 data-warehouse demonstrated strong performance in implementing complex inclusion/exclusion criteria.
  • A significant number of patients identified by the system were successfully enrolled in the trials.
  • The i2b2 extension successfully suggested a high number of potentially enrollable patients.

Conclusions:

  • The i2b2 data-warehouse is a valuable tool for enhancing the efficiency of clinical trial enrollment.
  • The developed i2b2 extension shows promise in improving patient identification and recruitment for studies.
  • Utilizing data-warehouse solutions like i2b2 can lead to better clinical trial outcomes.