Preclinical Models for Pulmonary Drug Delivery

Ibrahim, Jibriil; Bischof, Robert; McIntosh, Michelle Paula

doi:10.1201/9780429055201-30

Cited by 1 publication

(1 citation statement)

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“…Animal-based inhalation studies are carried out mainly in rats, mice or rabbits by exposure in restraint tubes [ 81 ]. Dogs and primates can also be used for testing OIDs in more realistic settings, via facemasks or helmets [ 82 ].…”

Section: Discussionmentioning

confidence: 99%

Preclinical Development of Orally Inhaled Drugs (OIDs)—Are Animal Models Predictive or Shall We Move Towards In Vitro Non-Animal Models?

Movia

Prina-Mello

2020

Animals

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Respiratory diseases constitute a huge burden in our society, and the global respiratory drug market currently grows at an annual rate between 4% and 6%. Inhalation is the preferred administration method for treating respiratory diseases, as it: (i) delivers the drug directly at the site of action, resulting in a rapid onset; (ii) is painless, thus improving patients’ compliance; and (iii) avoids first-pass metabolism reducing systemic side effects. Inhalation occurs through the mouth, with the drug generally exerting its therapeutic action in the lungs. In the most recent years, orally inhaled drugs (OIDs) have found application also in the treatment of systemic diseases. OIDs development, however, currently suffers of an overall attrition rate of around 70%, meaning that seven out of 10 new drug candidates fail to reach the clinic. Our commentary focuses on the reasons behind the poor OIDs translation into clinical products for the treatment of respiratory and systemic diseases, with particular emphasis on the parameters affecting the predictive value of animal preclinical tests. We then review the current advances in overcoming the limitation of animal animal-based studies through the development and adoption of in vitro, cell-based new approach methodologies (NAMs).

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Section: Discussionmentioning

confidence: 99%