Our Toxicology 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 services include:
- 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 12 months.
- 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.
- Where Relevant, Acute Studies - Acute toxicology in two mammalian species (rats and mice) after a single dose.
We offer a wide range of services to support you throughout the development process, including:
- 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.
- Histopathology services, either as part of studies conducted at Aptuit, or as a stand-alone service.