Inhalation Toxicity Studies
Adgyl Lifesciences offer well-controlled inhalation toxicity studies designed to evaluate systemic and local respiratory effects, supporting informed risk assessment and regulatory decision-making across development programs.
Inhalation studies are performed using nose-only exposure systems. We also provide inhalation studies in non-rodents such as canine and swine, in collaboration with a strategic partnered laboratory. Inhalation studies encompasses acute, repeat-dose studies of 7–14 days, 28 days, and up to 90 days. Exposure durations are flexible and can be adapted to meet specific regulatory or program requirements, enabling accurate dose-response evaluation and identification of target organs.
Our dedicated inhalation facilities support powder and aerosol exposures with robust atmosphere characterisation and monitoring. Integrated endpoints include exposure analysis at the breathing zone, pharmacokinetics, respiratory and systemic pathology, and detailed histopathological evaluations, ensuring a comprehensive assessment of inhalation safety.
Key Studies Include
- Acute inhalation study (4 hours continuous exposure or based on requirement)
- Repeat dose 7 to 14 days inhalation study (15 minutes to 6 hours continuous exposure/day or based on requirement)
- Repeat dose 28 days inhalation study (15 minutes to 6 hours continuous exposure/day or based on requirement)
- Repeat dose 90 days inhalation study (15 minutes to 6 hours continuous exposure/day or based on requirement)
Adgyl Lifesciences offers following IND enabling studies:
Exploratory studies (Non-GLP)
- Mini Ames
- Mini hERG (hERG screening)
- Dose range finding studies
- CVS function screening in telemetered dogs
Genotoxicity (GLP)
- Ames Test
-
In vitro Chromosomal aberration test in Human
Peripheral Blood Lymphocytes (MUT CHAB/HPBL) - Micronucleus test (MNT) in Mice/Rats
Process Hazard Analysis
- hERG assay
- Modified Irwin Test/Functional Observation Battery in rats (FOB-Rats)
- Pulmonary functions(Rats)
- CVS function assessment using telemetered dogs
Toxicology studies (GLP)
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Rat
- 28-Day Repeat dose toxicity study in Rat
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Dog
- 28 Day Repeat dose toxicity study Dog
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your inhalation toxicity studies.
what people ask
Frequently Asked Questions
What exposure methods are used in your inhalation studies?
We utilise nose‑only inhalation exposure systems to ensure precise and controlled delivery of test substances. This approach minimises non‑respiratory exposure and allows accurate assessment of inhalation‑specific effects.
What types of inhalation toxicity studies do you offer?
We offer a full range of inhalation toxicity studies, including acute inhalation studies and repeat‑dose studies of 7–14 days, 28 days, and up to 90 days. Study designs and exposure durations can be adapted based on specific project or regulatory requirements.
How do you ensure proper characterisation of the test atmosphere?
We perform detailed characterization of the inhalation atmosphere, including test item concentration, particle size distribution (MMAD and GSD), oxygen and carbon dioxide levels, temperature, and humidity, to ensure well‑controlled and reproducible exposure conditions.
Can inhalation studies be integrated with pharmacokinetic assessments?
Yes. Pharmacokinetics and exposure assessments in blood and/or tissues can be integrated into inhalation toxicity studies to support exposure–response evaluation and safety margin determination.
Are these inhalation studies suitable for regulatory submissions?
Yes. Inhalation toxicity studies are designed and conducted in alignment with applicable regulatory guidelines, supporting regulatory submissions and safety assessment.
