Toxicology Screening

As part of our toxicology services of optimal quality at competitive price, Accelera can perform, with minimum compound usage and limited cost, a set of studies to assess the safety profile of drug candidates and manage potential liabilities and issues prior to full development. This Tox Screening package includes:

Preclinical formulation
A simple formulation is developed for pre-clinical treatment, including solubility and short-term stability checking.

Pharmacokinetics
The experimental design is optimised to understand the PK profile and help design Safety/Toxicokinetic studies (2 groups of 3 animals, 2 dose levels or 2 administration routes).

Toxicity
Single ascending doses and repeated (up to 7 days at three dose levels) toxicology tests are carried out in 3 animals/sex. Hematology and clinical chemistry parameters are assessed at each dose change (single dose) or at the end of the treatment period. Necropsy with gross observation is performed at the end of the study; selected organs can be fixed and stained for histological examination.

Toxicokinetics
As part of the repeated dose study, systemic exposure to the test compound is monitored on day 1 and on the last treatment day using satellite animals. Plasma levels are measured using discovery-modeĀ bioanalytical methods to explore the correlation between exposure and adverse effects.

Timelines
  • Activities are started within 4 weeks from the service agreement signature.
  • Results are communicated in real time to the Sponsor by the Study Director.
  • Draft reports are available in 6 weeks from start of activities.