circulation, drug delivery by inhalation has a proven track record for safe and effective treatment of human respiratory diseases, principally asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and infection. However, in comparison with small molecule drug development, there exist some challenges to the development of effective and safe inhaled biological agent. Although many toxicological considerations for inhaled biopharmaceuticals are the same as small molecules, inhaled biopharmaceuticals have some specific features, such as relevant pharmacology, consistency of manufacturing processes, and immunogenicity, influence study design considerations.
Inhalation Toxicology Services at Creative Animodel
Creative Animodel provides integrated services at the early development of your inhalation drug, including providing technical and regulatory advice, conducting preliminary studies, and performing pivotal inhalation studies. We offer the following inhalation toxicology services for the development of your candidate drug:Neonatal inhalationAnti-asthmatic inhalationImmunologic sensitization via inhalationIntranasal inhalationIntratracheal inhalationAnti-asthmatic efficacyAcute to chronic toxicity, plus carcinogenicityNose-only and whole-body exposure of rodentsToxicokinetics of inhaled particlesLung function measurementRadiolabeled aerosol studies
Our AdvantagesRich experience in delivery of aerosols, vapors, and gases through the use of various nebulizers, atomizers, dry powder generators, gas/vapor generators, pressurized metered dose inhalers (MDIs), or dry powder inhalers (DPIs).A wide range of species available, including rat, mouse, dog, rabbit, guinea pig, hamster, minipig, pygmy goat, and cow.Various routes of administration, including nose only or whole body inhalation exposure (rodents), oronasal inhalation exposure (large animals), nasal dosing and intratracheal administration.Extensive knowledge and experience in aerosol science and inhalation exposure.Experience with complex test samples: powders, fibers, nanoparticles, and nanofibers.Personalized program design to meet your specific needs including non-standard and customized studies.
At Creative Animodel, we can conduct inhalation toxicity studies in accordance with international guidelines for regulatory agencies such as FDA, EPA, OECD, and others. By right of rich experience on inhalation studies, our team can provide comprehensive services of inhalation toxicology and custom solutions for global clients to meet specific requirements. If you have any questions, please feel free to contact us.
McElroy M. C., et al.; Inhaled biopharmaceutical drug development: nonclinical considerations and case studies. Inhalation toxicology, 2013, 25(4): 219-232.