Inhalation Toxicology
Inhalation toxicology studies are important in the assessment of the toxicity profile, especially on the respiratory tract organs and tissues, for novel drugs delivered via the pulmonary route in patients. It requires specialized capabilities and technical expertise to ensure that the right amount of compound is delivered effectively to the right target region. At Vectura Fertin Laboratories, you will find a dedicated team of experts and a range of specialised capabilities to efficiently assess the toxicity profile of your inhaled compound.
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Our Experience
Vectura Fertin Pharma Laboratories has more than 12 years of extensive experience conducting inhalation studies of various durations to identify acute to chronic toxicity effects and carcinogenicity. Specialized capabilities include generation of aerosols from test articles, delivery of aerosols to exposure chambers of various capacity, and characterization of aerosols to ensure the requisite size, the right concentration and quality throughout the exposure duration for effective delivery to test system.
Preclinical GLP Inhalation Studies
Our studies are performed in accordance to GLP standards and internationally accepted guidelines, including the 28-day (OECD TG412) and 90-day inhalation toxicity studies (OECD TG413).
Studies performed include:
- Dose range finding studies
- Single dose toxicity studies
- Repeated dose toxicity studies (up to 18 months) to identify acute, sub-acute, sub-chronic effects
- Chronic and carcinogenicity studies
A typical 90-day inhalation study design (OECD TG413). Reasonable modifications can be done upon request. TK: Toxicokinetics; RP: Respiratory physiology; UM: Urine metabolites sample collection
Study Endpoints
Exposure conditions:
- Aerosol parameters, where applicable (e.g. Total Particulate Matter (TPM), carbon monoxide (CO), chamber pressure, chamber flow rates, Particle Size Distribution (PSD)
- Test item concentration collected from chamber breathing zone
In life endpoints :
- General health parameters (e.g. daily or systematic health observations, body weight, food consumption, ophthalmology)
- Biomarkers of uptake or exposure. Compound or constituent may be measured in blood (serum or plasma) or urine
- Respiratory physiology (e.g. tidal volume, breathing rate, minute volume, peak inspiratory flow)
Terminal endpoints :
- Clinical chemistry
- Hematology
- Urinalysis
- BALF analysis (e.g. LDH, albumin, differential cell counts)
- Cell-free BALF protein analysis
- Necropsy (e.g. organ weights, gross pathological findings)
- Histopathology (sample processing, and histopathological evaluation)
Aerosol Sciences
In addition to our expertise in inhalation toxicology studies, Vectura Fertin Laboratories also provides specialized capabilities in aerosol generation, delivery and characterization via our in-house aerosol lab to help evaluate and optimize the generation of aerosols from your API formulations for further toxicology studies.
