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Practical Considerations in Dose Extrapolation from Animals to Humans.

Anthony J Hickey1, Sara E Maloney1, Phillip J Kuehl2

  • 1Department of Technology Advancement and Commercialization, RTI International, Research Triangle Park, North Carolina, USA.

Journal of Aerosol Medicine and Pulmonary Drug Delivery
|January 18, 2024
PubMed
Summary
This summary is machine-generated.

Extrapolating inhaled drug doses from animals to humans is complex due to biological differences. Understanding species-specific factors is crucial for accurate lung deposition estimates in drug development.

Keywords:
aerosol deliveryallometric scalingdoselung anatomylung functionspecies differences

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Area of Science:

  • Pharmacology and Toxicology
  • Drug Delivery Systems
  • Comparative Physiology

Background:

  • Animal studies are a cornerstone of drug development and regulatory review, with established practices spanning nearly a century.
  • Various experimental systems exist for generating liquid and solid aerosols for animal inhalation studies.

Purpose of the Study:

  • To highlight the challenges in extrapolating lung-deposited doses from animals to humans in inhaled drug delivery.
  • To emphasize the need for careful consideration of species-specific variables in dose scaling.

Main Methods:

  • The abstract does not detail specific experimental methods but discusses the principles of aerosol deposition and species comparison.
  • Focuses on factors influencing aerodynamic behavior and lung deposition across different species.

Main Results:

  • Extrapolation is challenging due to significant genetic, anatomical, physiological, and biological differences between species.
  • Inhaled drug delivery extrapolation is influenced by aerosol properties, delivery systems, and species-specific anatomy and pulmonary function.

Conclusions:

  • Accurate dose scaling requires acknowledging formulation, delivery system, and species-specific biological factors.
  • Scrutiny of inhaled drug delivery extrapolation is essential for reliable drug product development.