Toxicology Screening

As part of its offering 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 animal 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
A short repeat dosing study (typically 3 day or weekly x3) is performed in rodents (mouse or rat, single gender) by oral, IV bolus or SC administration at 3 dose levels. After last dosing, animals are sampled for laboratory investigations (hematology and clinical chemistry standard parameters) then sacrificed with gross pathology and histology on 5 selected organs.

Toxicokinetics
The systemic exposure to the test compound is monitored on day 1 using satellite animals. Plasma levels are measured using “discovery-mode” 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.