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Related Concept Videos

Compartment Models: Two-Compartment Model01:20

Compartment Models: Two-Compartment Model

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The two-compartment model divides the body into central and peripheral compartments to account for varying blood perfusion rates among organs and tissues, affecting drug distribution. The central compartment includes blood and highly perfused tissues with rapid drug distribution, while the peripheral compartment contains tissues with slower drug distribution. After a single IV bolus dose, the drug concentration is high in plasma and low in tissues. The drug distribution between compartments...
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Model Approaches for Pharmacokinetic Data: Compartment Models01:14

Model Approaches for Pharmacokinetic Data: Compartment Models

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Compartmental analysis is a widely adopted approach to characterizing drug pharmacokinetics. It uses compartment models that conceptualize the body as a collection of reversibly communicating compartments, each representing a group of tissues exhibiting similar drug distribution characteristics. The movement rate of the drug between these compartments is typically described by first-order kinetics.
Two primary types of compartment models are recognized: mammillary and catenary. The more...
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Two-Compartment Open Model: Overview01:05

Two-Compartment Open Model: Overview

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Multicompartmental models are crucial tools in pharmacokinetics, providing a framework to understand how drugs move within the body. The two-compartment model is a crucial subtype, segmenting the body into central and peripheral compartments. The central compartment represents areas with high blood flow, such as plasma and highly perfused organs like the kidneys and liver, while the peripheral compartment signifies tissues with lower blood flow, like adipose tissue and muscle tissue.
The...
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Bioequivalence Data: Statistical Interpretation01:16

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The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
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Model Approaches for Pharmacokinetic Data: Distributed Parameter Models01:06

Model Approaches for Pharmacokinetic Data: Distributed Parameter Models

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Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
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Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches01:14

Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches

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Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
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23andMe: a new two-sided data-banking market model.

Henri-Corto Stoeklé1,2, Marie-France Mamzer-Bruneel1,3,2, Guillaume Vogt4,5,6

  • 1Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.

BMC Medical Ethics
|April 10, 2016
PubMed
Summary

23andMe built a large DNA biobank for research and profit by selling genetic tests. Ethical issues arise from this direct-to-consumer model, which combines personal genetic information with scientific and financial gain.

Keywords:
BiobankingData bankingDirect-to-consumer (DTC) genetic testingEthical issuesResearchServiceTwo-sided markets

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Area of Science:

  • Genetics and Genomics
  • Bioethics
  • Consumer Health Technology

Background:

  • Direct-to-consumer (DTC) genetic testing company 23andMe collected samples and data from over 1 million individuals since 2006.
  • The US Food and Drug Administration (FDA) halted sales of 23andMe's genetic health reports in 2013 due to unproven reliability.
  • Despite the halt, 23andMe continued health research with existing and future samples, and later received FDA authorization for specific carrier status reports.

Purpose of the Study:

  • To analyze the dual objectives of 23andMe: market promotion and biobank establishment.
  • To examine the creation of a two-sided market between consumers and research laboratories.
  • To highlight the significant ethical considerations associated with 23andMe's business model.

Main Methods:

  • Analysis of 23andMe's business practices and market strategy.
  • Review of regulatory actions by the FDA concerning genetic health tests.
  • Examination of the ethical implications of large-scale biobanking and data utilization in direct-to-consumer genetic testing.

Main Results:

  • 23andMe aimed to establish itself in the predictive genetic testing market while building a valuable DNA and personal information biobank.
  • A two-sided market was created, facilitating scientific and financial gains through consumer data.
  • The company's approach raises profound ethical questions regarding data privacy, consent, and commercialization.

Conclusions:

  • The 23andMe model created a unique market dynamic for genetic data.
  • Ethical scrutiny is essential for direct-to-consumer genetic testing companies leveraging large biobanks.
  • Balancing consumer access, research advancement, and ethical considerations remains a critical challenge.