Safety Assessment

We can help you identify which compounds have the optimal ADME and safety profile to advance into the clinic. Our experience extends from early discovery through to the clinic so we have a full picture of the entire drug discovery and development continuum and can support you at every stage of your project. The scientific expertise and capabilities can be accessed as fee-for-services or as part of partially or fully integrated programs.

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.

Drug toxicity is a key reason for drug attrition. Identifying potential toxicity and understanding mechanisms of toxicity at an early stage in drug discovery can save both time and developmental costs, and allows the safest compounds to be progressed into preclinical development. As a consequence, human relevant cell-based models are being introduced in drug discovery to address this need. Evotec and wholly owned subsidiary Cyprotex are leading the science in this field and have significant expertise in the latest techniques such as high-content imaging, microelectrode array, 3D cell and iPSC-derived models and transcriptomics.

Regulated safety assessment studies are still an important part of the preclinical drug development process and are a requirement prior to an investigational drug reaching the clinic. Evotec’s Safety Assessment offers a full range of services from exploratory programs to fully GLP-compliant toxicology studies. These can be performed either as standalone services or part of a fully integrated preclinical development package.

At Evotec, our dedicated team of pathologists and histology scientists, supported by renowned external consultants, collaborates to assess drug candidate safety and efficacy. Our experts bring decades of experience in laboratory animal pathology and histotechnology, aiding drug development from discovery to safety studies. We specialize in toxicological assessments, biomarker identification, and maintaining rigorous quality standards. Join us in reshaping medicine through groundbreaking research and innovation. Explore our services and collaborate for a healthier future.

ADME (absorption, distribution, metabolism and excretion) studies can be used to estimate the plasma and tissue concentrations in the body (pharmacokinetics). There is a clear link between pharmacokinetics/tissue exposure and clinical efficacy and safety due to either on-target or off-target effects.

Evotec and its wholly owned subsidiary Cyprotex offer a comprehensive and flexible range of in vitro and in vivo DMPK/ADME studies designed to cover the majority of all activities in the hit-to-lead and lead optimization phase through to candidate selection up to Phase II. We also offer in vitro metabolite profiling, structural elucidation and DDI (drug-drug interaction) studies for IND and NDA submissions during preclinical development and clinical stage projects.

Evotec and its subsidiaries have a breadth of experience in bioanalysis for small molecules and bio-therapeutics of any size: peptides, recombinant proteins, monoclonal antibodies, oligonucleotides, as well as anti-drug antibodies, vaccines, cell therapies and gene therapies, for non-clinical and clinical sample analysis. The scientific experience, capacity and application of the state-of-the-art bioanalytical equipment provide fast turnaround that will help to arrive at “go/no-go” decisions faster. Our bioanalysis service is part of both standalone services as well as fully-integrated packages.

We can offer both non-GLP and GLP bioanalytical services with validated methods appropriate for regulatory submissions.

INDiGO is the fastest and most efficient approach to bring a program from candidate selection into clinical development. Our unique R&D site in Verona, Italy (formerly a Glaxo-Smith Kline Center of Excellence) co-locates manufacturing and non-clinical development, providing a unique opportunity to fully integrate all aspects of drug development.

Abuse liability assessment refers to the testing of a neuroactive substance for its potential to become a drug of abuse. At Evotec we have significant expertise and experience to design an abuse liability strategy and deliver all the required studies.