Nonclinical Services

iNGENū provides full end-to-end nonclinical research advisory services and can execute the standard FDA IND-enabling sequence of nonclinical studies.

Provision of Comprehensive Nonclinical Services

  • Genetic Toxicology (“Genotox”) Battery (Ames Test, Chromosomal Aberration Assay, In Vitro Mouse Micronucleus, COMET study)
  • Rodent and Second Species (dog, minipig, rabbit, NHP) GLP Toxicology for 4, 7, 28 days or chronic multi-dosing as specified by the FDA depending on the planned investigational product dosing strategy
  • Safety Pharmacology Studies including Cardiovascular Telemetry Studies in dogs, Respiratory Studies (plethysmography in rats), and CNS Studies (modified Irwin test in rats)
  • Bioanalytical Services needed (analytical method development, method validation, sample analysis)
  • Full ADME Services (in vitro assays and PK in rodent, dog or minipig)
  • Reproductive Toxicology
  • Carcinogenicity Studies

Cost & Time Reduction

Our nonclinical research strategy advisory is primarily based on the M3(R2) FDA guidance for nonclinical safety studies.

For our clients seeking first-in-human clinical trials in Australia, a more abbreviated nonclinical study programme is usually possible.

Whilst due to local legislation, not all the in-life studies will be performed in Australia and can be performed at partner labs as per the multisite principles of GLP.

Nonclinical research (inclusive of both the in-life work and the bioanalytical work) is still eligible for the Australian Government 43.5% R&D Incentive in the same manner as clinical research.

This results in nonclinical research performed in Australia typically being 70-75% cheaper than similar studies being performed in the USA.

Additionally, the lag in North America to start second species (notably dog and NHP species) toxicology can be up to 9-12 months.

This level of delay is not being experienced in Asia-Pacific with animal studies being available within relatively short timeframes.

Ready to discuss your trial?