Nonclinical Safety Assessments

GLP inhalation toxicology studies are at the core of our expertise.

Support in ALL routes of administration

We offer the following standard routes of administration for general toxicology studies and are happy to advise further on the most suitable route to meet your needs.

General Toxicology

Acute Toxicity studies

Dose range finding studies to evaluate MTD and acute toxicity effects

Sub- acute and sub-chonic Toxicity Studies

Repeated dose studies to evaluate the sub-acute and sub-chronic toxicity effects over a 28-day or 90-day study duration

Carcinogenicity Toxicity Studies

12 or 24-months mouse or rat studies, and 6- month rasH2 transgenic mouse study

Genotoxicity

Mammalian Erythrocyte Micronucleus Test (OECD TG474)

Principal endpoints include:

  • Frequency of micronucleated immature erythrocytes in bone marrow or peripheral blood samples
  • Frequency of mature erythrocytes that contain micronuclei in peripheral blood samples
  • In-life assessments include body weight monitoring and clinical observations.

In-life assessments include body weight monitoring and clinical observations

Safety Pharmacology Studies

CNS safety pharmacology

Respiratory safety pharmacology

Cardiovascular safety pharmacology*

Developmental and Reproductive Toxicology Studies

Segment I: Fertility and embryonic development

Segment II: Embryo-fetal development (two species)*

Segment III: Prenatal and postnatal development

*Outsourced studies to our GLP-compliant partner labs located in North America, Asia, and Europe. We monitor and provide our expertise and oversight to these studies from in-life to reporting stage.

At Vectura Fertin Pharma Laboratories, your research goals are our priority