Safety Assessment Services
Home to a staff of over 1,000 scientists, technicians, and support personnel, our 44-acre site near Edinburgh, UK features expansive facilities for the development of human and veterinary pharmaceuticals, industrial chemicals, agrochemicals and animal health products, including 112 animal rooms, 28 research grade glasshouses, and 120 acres of fields and paddocks.
Here, toxicologists and analytical scientists work together to streamline your programs and optimize study designs, thus maximizing your budget while mitigating risks. Continued investment in regulatory initiatives such as SEND ensures consistent, timely data submissions.
Acute to Chronic Toxicology
Access a comprehensive range of toxicity studies in all recognized laboratory animal species. Beyond the full range of routine clinical dose routes, our team has extensive experience in non-standard routes of administration and numerous established disease models.
Whether you’re developing pharmaceuticals, industrial chemicals, or agrochemical products, our dedicated inhalation toxicity team can assess the effects of exposure to your compound in numerous formulations, including liquids, vapors, dust, powders and UVBCs. Studies are available in rodent and nonrodent species, from single dose and sub-chronic through chronic and carcinogenic. The team is also skilled in the conduct of radiolabeled aerosol disposition studies as well as specialty neonatal, reproductive, and neurotoxicologic endpoints.
Evaluate the efficacy and safety of your parenteral drug formulations with expert design and conduct of robust infusion studies. With decades of experience, our team can help you overcome the challenges and establish the most appropriate method, drawing from our deep knowledge of intravenous and subcutaneous infusion, external delivery systems, implantable osmotic pumps, and programmable micro-infusion pumps.
Developmental and Reproductive Toxicology (DART)
From program planning and individual study design to execution per internationally recognized guidelines like ICH and OECD, our skilled team can help you satisfy complex developmental and reproductive toxicology (DART) requirements.
Available study designs include:
• OECD 414 Prenatal Developmental Toxicity Study
• OECD 416 Two-Generation Reproduction Toxicity
• OECD 421 (Screening) or OCED 422 (Combined) Reproductive Toxicology Study
• OECD 443 Extended One Generation Reproductive Toxicity Study
• OECD 426 Developmental Neurotoxicity Study
Drug Metabolism & Pharmacokinetics
The scientists at the Edinburgh facility can design the optimal DMPK/ADME program to support your drug discovery and development needs:
• In vitro metabolism
• In vivo ADME
• Mass balance
• QWBA (tissue distribution)
• Clinical metabolism support
• Metabolite profiling and transformation
In Vitro Toxicology
The in vitro scientists at Edinburgh perform a range of studies to support dermal absorption and metabolism, safety pharmacology, and respiratory toxicology. Our world-renowned experts can also leverage bespoke and innovative technologies to design and evaluate new in vitro assays.
From early discovery and nonclinical development (where developing and refining methods in a variety of species and biological matrices is critical) to the later clinical stage challenges of sample collection, logistics and handling, and significant data management, our expert analysts leverage state-of-the-art technology to ensure a streamlined bioanalytical service that helps you make confident research decisions.
Trust our team to develop or transfer, optimize, validate, and apply quantitative bioanalytical methods to measure drug and metabolite concentrations for samples of almost any biological fluid, including both standard whole blood, plasma, serum, cerebrospinal fluid (CSF), urine, and more unconventional matrices such as liver, brain, kidney, lung, muscle and skin.
The Edinburgh team can support you with deep scientific expertise on immune system function, as well as an up-to-date knowledge of regulatory expectations, and established immunology testing:
• Development & validation of immunology methods
• Clinical biomarkers
• Cell-based functional assays
Experienced analytical scientists at the Edinburgh facility provide support for toxicology, metabolite ID and residue studies:
• Chemical analysis of dose formulations, inhalation chamber atmospheres and bulk test article
• Chromatography method development
• Sample preparation method development
• Extraction of bound residues
• Radiochromatographic profiling
• Isolation and purification of metabolites
• Metabolite identification using LC-MS/MS, QToF and IT-ToF
Molecular Biology Services
Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Learn More.
Anatomic and Clinical Pathology
A comprehensive range of specialty, pathology-based services are available at the Edinburgh site:
• Peer review
Our Edinburgh facility has been serving the testing and regulatory needs of the world’s agrochemical and biocidal companies for nearly half a century. Trust the registration of your new and existing active ingredients to the team with a proven track record for developing tailored study programs that satisfy regulatory requirements of your intended markets. With access to the full range of chemistry, in vitro and in vivo toxicology, metabolism, environmental studies, field trials, residue analysis, and human exposure studies, we can design and manage entire agrochemical programs that minimize risk and meet your milestones.