Irwin`s test in rodent

Aim: To assess the effects on general activity and behaviour of the test item after single dose administration in rodents. 

Background information: The assessment of potential undesirable pharmacodynamic effects on the central nervous system is a regulatory requirement for the development of new therapeutic agents (ICH S7A). As such, these studies must be conducted under GLP-compliance and generally in advance of first in human administration (ICH M3(R1)). To this respect, the modified Irwin’s test allows to assess effects on motor activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature.

Further to this, the preliminary assessment (under non-GLP conditions), during the candidate selection phase, of potential undesirable effects on the central nervous system can help to de-risk the selection process and increase the chance for success.

In this modified Irwin’s test, animals are administered different single dose levels of the test item to identify potential therapeutic uses and in the selection of appropriate doses for subsequent assays. 

GLP-status: both GLP-compliant & non-compliant, on demand

Animal species: mice or rats

Compound requirement: according to test species & dose levels

Turnaround time: 1 week after experimental completion week

Experimental procedure

  • 4 to 6 animals/sex/group, doses with: 
  • Test item; 3 dose levels
  • Formulation vehicle (vehicle control)
  • Positive control (on demand)
  • Route of administration: as per clinical use
  • Follow-up period of up-to 7 days, observation of clinical signs & mortality
  • Animal necropsy and/or blood sampling on demand

Delivered results

  • Absence/presence of effects on the central nervous system

We are proud to announce that Welab is partner of this new EU funded project.

In collaboration with 12 partners from 6 countries, Welab Barcelona is establishing the Antivirus Pandemic Preparedness EuropeAn pLatform (APPEAL), a European research initiative aimed at enhancing preparedness for future pandemics. This EU funded collaboration will establish a comprehensive program for the development of broad-spectrum antiviral drugs within a five year time frame ensuring drug affordability and accessibility to low income countries.
Link to the press release: https://lnkd.in/d-jmV2CS