Spread the Word: IITRI has 40+ Years of Experience in GLP Inhalation Studies

Many inhalation professionals are unaware that IITRI provides complete end-to-end inhalation toxicology study programs for IND and NDA submissions. We have decades of expertise in aerosol science, inhalation exposures and study teams headed up by PhD and DABT toxicologists.

With over 40 years of experience with inhaled drug studies and an expanded staff, IITRI is worth a closer look. Our comprehensive preclinical inhalation toxicology services include development of inhaled drugs, infectious aerosol challenge studies, occupational health, environmental risk assessments, and electronic cigarette or flavor studies.

For those that are new to conducting inhalation studies, IITRI offers a more customer-centric experience to help guide you through the process. Our highly experienced team is ready to help fill in any gaps you may have.

Based on your needs, we can provide customized solutions including:

Test atmosphere generation

 Nose only or whole body inhalation exposure (rodents)

Oronasal inhalation exposure (large animals)

 API-sparing dry powder or liquid intratracheal administration for use with limited availability of test article

Intranasal dosing

 

Meet our Inhalation Toxicology Team

Sridhar Jaligama, PhD, DABT

Deputy Division Manager

Dr. Sridhar Jaligama recently joined us as the Deputy Division Manager of Inhalation Toxicology.

As a board-certified toxicologist with 10+ years of experience in toxicology, he brings specific expertise in the design and conduct of complex inhalation toxicology programs in support of regulatory submissions for various industries.

 He also brings a deep understanding of FDA regulations as it relates to non-clinical development along with a strong expertise in the conduct of non-clinical inhalation toxicology studies for FDA Pre-market Tobacco Applications.

Scott Garthwaite, BS

Inhalation Engineer

Scott has 35+ years of experience in inhalation toxicology. He has designed and built exposure systems for dusts, aerosols, fumes, vapors, MDI’s, DPI’s and a variety of consumer products for small animal (rodent) and large animal studies. 

He has performed pulmonary physiology and safety pharmacology using non-invasive and implantable devices for lung function and cardiovascular measurement. With a degree in chemical engineering, he has also performed chemical analysis of test atmospheres, dosing formulations and biological samples. 

Some of the larger and more complex programs he has worked on include tobacco and chemical industry studies using FDA regulations and submissions.

 

Ben Chen, PhD

Head of Inhalation Technologies

Dr. Chen has 20+ years of work experience in respiratory research, stemming from chemical engineering and moving into in-vivo biology (mice, rats, dogs, and non-human primates), pulmonary mechanics, respiratory physiology, aerosol generation, particle measurement, and controlled deposition.

He also is experienced with respiratory diseased animal models, imaging-based biomarkers (MR, CT and PET), respiratory therapeutics R&D, inhalation devices, inhalation exposure, lung histopathology, and inhalation toxicology.

Dr. Chen leads the studies in our new bleomycin mouse model for pulmonary fibrosis (see above).

IITRI provides IND-enabling vaccine programs, with over 30 years of experience conducting GLP-compliant toxicology studies. We support vaccine basic research through FDA approval programs for sponsors from government, biotech, academic, and pharma institutions.

Our team would love to speak to anyone looking to test their candidates, feel free to contact us.