Nonclinical Safety Assessment

Preclinical toxicity studies are required during drug development to ensure safety prior to clinical trials. It is an essential part of the regulatory approval process for drugs. As well as identifying any adverse effects, these studies can help to understand appropriate dose regimes for the drug candidates.

Evotec’s Safety Assessment offers a full range of services from exploratory programs to fully GLP-compliant toxicology studies with the aim to establish the toxicological profile of new compounds or to extend the known profiles of existing ones (new indications, new formulations, new routes of administration). The Safety Assessment activities can serve also as part of an INDiGO program, Evotec’s solution designed to de-risk and accelerate IND-enabling programs. 

Preclinical toxicity studies are required during drug development to ensure safety prior to clinical trials. Here at Evotec, we offer a full range of services from exploratory studies to fully GLP-compliant toxicology programs with the aim of establishing the toxicological profile of new compounds or to extend the known profiles of existing ones (new indications, new formulations, new routes of administration).  These Safety Assessment activities can serve also as part of an INDiGO program, Evotec’s solution designed to de-risk and accelerate IND-enabling programs.  Whether standalone or integrated, our team use their vast experience to design the best approach to fully characterize your candidate and help to maximize the probability of success.

• Dose Range Finding/Maximum Tolerated Dose Studies: These preliminary studies establish initial safety and identify appropriate dose levels for subsequent regulatory toxicological studies.

• Regulatory Repeat Dose Toxicology Studies: These studies are required by regulatory authorities before initiation of clinical trials to identify any potential safety liabilities and inform dose selection and safety monitoring for subsequent clinical trials.

• Oral (gavage, diet and capsule)
• Parenteral (intravenous, subcutaneous, intradermal, intramuscular and intraperitoneal)
• Intraarticular
• Intrathecal
• Infusion toxicology (intermittent and continuous infusion models for rodent and non-rodent species)

The team is developing models to test toxicities and efficacy of drugs in tissues such as the lung.

At Evotec, GLP and international regulatory standards are applied to all pathology activities to support rigorous toxicological assessment aimed at evaluating the potential adverse effects of drug candidates. Although our pathology unit is primarily dedicated to toxicological pathology in preclinical safety studies, we have the skills to support also investigative early safety studies, validation and characterization of animal models, phenotyping studies and identification and validation of novel biomarkers.

• Rodent micronucleus test (in vivo)
• Bacterial mutation test (in vitro Ames)
• Mammalian chromosome aberration (in vitro HPLA)
• Mammalian cell micronucleus test (in vitro)

• In vivo studies
  • CV in vivo telemetry (all species)
  • Neurobehavioral FOB  (all species)
  • Respiratory function - WBP (rodent)
  • Combined neuro-cardio model (non-rodent)
  • Abuse liability studies

• In vitro assays
  • Cardiac safety panel in manual patch-clamp (GLP/non-GLP)
  • Microelectrode array (MEA; non-GLP, neuro/cardio)
  • 3D cardiac models (non-GLP)
  • In vitro neurite outgrowth