Practical Considerations in Dose Extrapolation from Animals to Humans.
J Aerosol Med Pulm Drug Deliv
; 37(2): 77-89, 2024 Apr.
Article
em En
| MEDLINE
| ID: mdl-38237032
ABSTRACT
Animal studies are an important component of drug product development and the regulatory review process since modern practices have been in place, for almost a century. A variety of experimental systems are available to generate aerosols for delivery to animals in both liquid and solid forms. The extrapolation of deposited dose in the lungs from laboratory animals to humans is challenging because of genetic, anatomical, physiological, pharmacological, and other biological differences between species. Inhaled drug delivery extrapolation requires scrutiny as the aerodynamic behavior, and its role in lung deposition is influenced not only by the properties of the drug aerosol but also by the anatomy and pulmonary function of the species in which it is being evaluated. Sources of variability between species include the formulation, delivery system, and species-specific biological factors. It is important to acknowledge the underlying variables that contribute to estimates of dose scaling between species.
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Base de dados:
MEDLINE
Assunto principal:
Sistemas de Liberação de Medicamentos
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Pulmão
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article