Toxicology

Successful drug development requires precise evaluation of the safety profile of new drug candidates. Selvita’s toxicology group supports drug safety assessment by offering our clients preclinical non-GLP standard and customized studies in rodent and non-rodent models as a part of integrated drug discovery projects or as a stand-alone service.

We implement high quality standards to discharge in vivo safety liabilities through tailored study design. Our broad experience with different targets and mechanisms allows us to deal with unexpected findings or toxicity issues during the course of the research projects. We offer you investigative, problem-solving studies with fit-for-purpose, integrated assessment of multiple endpoints (general toxicology, clinical biochemistry, pathology and bioanalysis).

In vivo experiments are performed in AAALAC-I accredited State-of-the-Art animal facility (BSL2) with competent and skilled veterinary doctors, veterinary technicians and hygiene personnel holding training certificates equivalent to FELASA categories A to D. Our highly experienced toxicology team comprises toxicologist, certified toxicological pathologist and clinical pathologist. Animal-related research is based on the 3R principles and high-performance standards ensuring animal welfare, humane and ethical use of animals in scientific research.

Selvita routinely performs the following comprehensive toxicology services (according to ICH guidelines):

• Single Dose Toxicity
  • Acute toxicity studies (rat, mouse)
  • MTD (Maximum tolerated dose) studies (rat, mouse)
• Repeat Dose Toxicity
  • MTD (Maximum tolerated dose) study (rat, mouse) for three or more days of dosing
  • 3-7-day toxicity study in rodents including toxicokinetics, clinical pathology, histopathology (rat, mouse)
  • 14-day DRF (dose range finding) study in rodents including toxicokinetics, clinical pathology, histopathology (rat, mouse); with or without recovery period
  • 28-day toxicity study in rodents including recovery and toxicokinetics, clinical pathology, histopathology (rat, mouse)
• Local tolerance studies, Acute dermal irritation (rabbit)
• Custom-made studies/models

In support of the general toxicology studies, our fully equipped biochemistry laboratory provides automated hematology, coagulation and clinical biochemistry analysis. Pathology services include organ macroscopic evaluation and histopathological examinations (FFPE, standard and special staining, IHC, IF, ISH, digital image analysis) with special assessment available for nephrotoxicity. In addition, our bioanalytical platform can deliver high quality pharmacokinetic analysis of Your drug candidates.

You can benefit from flexible study design (total animal number, route and dose of administration, study duration) and a combination of standard or specialized read-outs that will optimally address Your drug development project.

For further details on toxicology models available at Selvita, please contact us.