Our global Toxicology and Pathology group provides you with a tailored approach designed to address your regulatory needs, with standard and customized studies in rodents, dogs, and primates. We can also assist in designing development programs, compiling expert reports, and completing data submissions.

Toxicology and Pathology services include:

• Pre-candidate screens in rodents - This study forms part of a pre-development general toxicity screen with the primary objective to identify toxicity that could complicate or preclude its subsequent development. It can also consist of a comparative study, helping you to screen out one or several compounds with a prohibitive in vivo safety liability
• Maximum Tolerated Dose (MTD)/Dose Range Finding (DRF) Studies - Routinely performed to determine suitable doses for pivotal studies.
• 14- or 28-day Studies - Pre-phase I, with or without a recovery assessment. For most small molecule programs, repeat dose studies are performed in two mammalian species (rodent and non-rodent), with the duration dependent on the duration, therapeutic indication and scale of the proposed clinical trial. For biologicals and biotechnology compounds, depending on the species specificity of the molecule, repeat dose studies may only need to be performed in one mammalian species.
• Chronic Toxicology Studies - Three months through 9 months.
• Short term infusion studies - IV administration up to 4 hours duration in rat and dog
• Immunotoxicology - Identification of compounds with immunotoxic potential can be achieved with studies performed according to ICH S8 guidelines. In conjunction with our immunoassay group, we offer validated methods to determine T-cell dependent antibody responses, immunophenotyping and natural killer cell activity.
• Extended Acute Studies - Designed to support single-dose studies in human under specific regulatory paradigms as described in ICH M3.
• Investigative & problem solving studies - customised, fit-for-purpose, integrated assessment of multiple endpoints (Safety Pharmacology, General Toxicology, Pathology and DMPK endpoints).
• Integration of Safety Pharmacology endpoints in General Toxicity studies as recommended by a number of Regulatory guidances, including the recent ICH M3, e.g. Neurobehaviour/CNS function (also via video monitoring) or ECG acquisition via telemetry in freely moving animals.
• Non-Clinical Assessment of Safety, Regulatory documents preparation and interaction with National and International Regulatory Authorities
  

We offer a wide range of services to support you throughout the drug discovery and drug development process, including:

• Safety liability assessment of biological targets, that is an evaluation of Target Biology through the eyes of a toxicologist. Hypothetical target organs/toxicities based on target expression and function, genetic or disease models, competitive intelligence will be identified.
• In silico (computational) assessment of scaffold/candidate drugs (as well as metabolites and/or impurities) for prediction of potential safety liabilities
• In vitro haemolysis on animal or human blood
• Cutting edge pathology tools and expertise in Diagnostic Veterinary pathology
• Dedicated formulation group to support toxicology studies, formulating dosing solutions, or suspensions from supplied compounds. We can provide advice on formulation method development, or use an existing method.
• Formulation analysis support. We can develop methods or transfer and validate existing methods.
• Bioanalytical and toxicokinetic support. We offer full on-site GLP and GCLP bioanalytical services and a specialized toxicokinetics/biostatistics group.
• Clinical pathology support. Our dedicated laboratory facility offers a full range of standard as well as specialized services.