Safety assessment

 

Evotec’s Safety Assessment offers a full range of services from exploratory programmes 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 team includes dedicated study directors, all experts in their fields with years of experience, who apply their project-leadership expertise to design and manage the studies and deliver final reports on time. All study directors have degrees in life sciences.

The Safety Assessment activities can serve also as part of an INDiGO programme, Evotec’s solution designed to de-risk and accelerate IND-enabling programmes. 

The safety assessment department works closely with other Evotec teams (i.e. formulation development and dispensary, bioanalysis, ADME, pathology services, biometry) that provide ancillary services necessary to complete a safety assessment. 

Our range of services and capabilities include:

  • Non-GLP acute toxicology
  • Dose range finding/maximum tolerated dose studies; a rapid assessment of the toxicological profile to establish initial safety and facilitating subsequent regulatory toxicological studies
  • General toxicology; repeated dose toxicity based on available PD, PK, and toxicological information from previous studies, as well as the intended clinical use
  • In vitro toxicology
  • Neurotoxicology
    • Abuse liability studies
    • In vitro microelectrode array (MEA; non-GLP)
    • In vitro neurite outgrowth 
  • Genetic toxicology
    • In vivo genotoxicity assays
      • Rodent micronucleus test
    • In vitro genotoxicity assays
      • Bacterial mutation test (Ames)
      • Mammalian chromosome aberration (HPLA)
      • Mammalian cell micronucleus test 
  • Infusion toxicology (intermittent and continuous infusion models for rodent and non-rodent species)
  • Safety pharmacology
    • In vivo studies
      • CV in vivo telemetry all species
      • Neurobehavioral FOB  all species
      • Respiratory function - WBP (rodent)
      • Combined neuro-cardio model (non-rodent)
    • In vitro assays
      • Cardiac safety panel in manual patch-clamp (GLP/non-GLP)
      • Microelectrode array (MEA; non-GLP)
      • 3D cardiac models (non-GLP)
  • Hepatotoxicity
    • In vitro 3D liver cell-based models (non-GLP)
    • In vitro DILI panels (non-GLP) 
    • Transcriptomic analysis (non-GLP)
  • Nephrotoxicity
    • In vitro 2D and 3D cell-based models (non-GLP)
  • Routes of administration
    • Oral (gavage, diet and capsule)
    • Parenteral (intravenous, subcutaneous, intradermal, intramuscular and intraperitoneal)
    • Intraarticular
    • Intrathecal

Safety Assessment is part of fully-integrated packages, including all aspects of drug development in a single site (INDiGO). 
The team is developing models to test toxicities and efficacy of drugs in tissues such as the lung.

You might also be interested in

Our INDiGO services

Contact us

Evotec

Business Development

T +44.(0)1235.86 15 61 F +44.(0)1235.86 31 39 vCard
TOP