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Related Concept Videos

Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Drug Dosage Regimen: Overview01:15

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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
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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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Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

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Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
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Related Experiment Video

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Developing statewide remdesivir use criteria.

Erin R Fox1, Mark Shah2, Russell Vinik3

  • 1University of Utah, Drug Information Service, Salt Lake City, UT, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|January 23, 2021
PubMed
Summary
This summary is machine-generated.

Four Utah health systems collaborated to create standard use criteria for remdesivir, a critical coronavirus disease 2019 (COVID-19) treatment, ensuring equitable access to the limited therapeutic agent.

Keywords:
COVID-19remdesivirshortagesupply and distribution

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Area of Science:

  • Health policy
  • Infectious disease management
  • Pharmaceutical therapeutics

Background:

  • Limited supplies of critical treatments like remdesivir necessitate rationing criteria.
  • Existing Emergency Use Authorization (EUA) criteria can lead to broad treatment access, exacerbating supply shortages.
  • The absence of national guidelines requires individual health systems to develop their own allocation strategies.

Purpose of the Study:

  • To describe a collaborative process for establishing standard use criteria for remdesivir in Utah.
  • To develop a framework for managing limited therapeutic agent supplies during the COVID-19 pandemic.
  • To provide insights for future resource allocation of novel treatments like vaccines and monoclonal antibodies.

Main Methods:

  • A workgroup comprising infectious diseases specialists, chief medical officers, and pharmacists from Utah's four largest health systems was formed.
  • The group convened multiple online meetings and communicated via email over a nine-day period.
  • A consensus-based approach was used to develop rationing criteria for remdesivir.

Main Results:

  • Statewide criteria for remdesivir use were successfully established.
  • The collaborative effort ensured consistent access to remdesivir for COVID-19 patients across Utah.
  • The developed framework is adaptable for future therapeutic agents facing supply constraints.

Conclusions:

  • A unique, multi-system collaboration in Utah resulted in standardized criteria for remdesivir utilization.
  • This initiative ensured equitable access to a limited, life-saving treatment for all COVID-19 patients in the state.
  • The established framework serves as a model for managing scarce resources and developing criteria for future therapeutics.