While oral or injected dosing of animals is straightforward, inhaled administration of drugs presents technical and logistical challenges. This article outlines considerations and industry practices for performing non-clinical studies in support of inhaled drug development. Topics include selection of test species, generation of the test atmosphere and its presentation to animals, aerosol characterization, dosimetry and pulmonary deposition of inhaled test materials.
Studies characterizing the toxicity of drugs (and, ideally, non-clinical efficacy studies) dose animals via the most clinically relevant route. While oral or injected dosing of animals is straightforward, inhaled administration of drugs presents technical and logistical challenges. This article provides an overview of considerations and industry practices for performing non-clinical studies in support of inhaled drug development. Topics include selection of test species, generation of the test atmosphere and its presentation to animals, aerosol characterization, dosimetry and pulmonary deposition of inhaled test materials.