inhaled covid-19 drugs

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inhaled covid-19 drugs

For Vaccines and Drug Development

At IITRI, we have the full capabilities to take your inhaled drug candidate from efficacy in a COVID-19 animal model to providing full IND-enabling program support. We can do multiple routes for the SARS-CoV-2 challenge including intranasal or aerosol delivery in our BSL-3 / ABSL-3 containment facilities. We also have a supporting bioanalytical department as well.

aerosol development and characterization

The development of methods for exposure atmosphere generation with a particle size range allowing lung deposition is the first step in any inhalation study. Preliminary method development activities include:

Development and optimization of methods to generate the test atmosphere, including a determination of the Maximum Feasible Concentration (MFC).
Characterization of test atmosphere, including test article concentration; particle size distribution (Mass Median Aerodynamic Diameter and Geometric Standard Deviation), spatial uniformity and temporal stability evaluations that encompass the maximum intended duration of in vivo exposure.
Technology transfer of the method for quantitative analysis of test article in exposure system filters (HPLC; to permit characterization of exposure levels)

Efficacy studies

We offer multiple animal models for COVID-19 challenge studies. Our infectious disease group works closely with our inhalation toxicology team to administer your inhaled drug as either a prophylactic or treatment under ABSL-3 containment.

Aerosol Method Development: Aerosol method development and characterization will be performed as part of the method development and characterization (see above).
Exposure characterization is limited to gravimetric filter analysis if the study needs to be conducted in an ABSL3. Collection of impinger samples and chemical analysis can be performed at additional cost.
Possible endpoints include: nasal washes (hamster and ferrets), clinical observations, body weight, body temperature, interim sacrifices, viral titers, collection of tissues for histopathology.

inhalation toxicology programs

Our comprehensive preclinical inhalation toxicity testing programs utilizing pulmonary drug delivery are customized to support GLP-compliant IND submissions for pharmaceuticals and the intended inhalation delivery device. We also offer early preclinical and NDA-enabling inhalation toxicology services for complete end-to-end coverage of regulatory requirements.

Acute, subchronic and chronic inhalation toxicology studies
PK and biodistribution: see API-Sparing Techniques for Inhalation Toxicology Studies
Developmental and reproductive toxicology studies with inhalation exposure
Carcinogenicity studies

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