Toxicology Studies
General toxicology studies are a crucial regulatory step in drug development. The primary purpose is to ensure that only drug candidates with a solid safety profile proceed to First-in-Human (FIH) studies. Toxicological studies involve two animal species – a rodent model and a non-rodent model. They require systemic drug administration to ensure it circulates through the bloodstream and reaches all vital organs. The protocols follow guidelines tailored to the compound under investigation.
Study Types
Scantox offers the full spectrum of toxicology services, including GLP. We support every step of preclinical drug development. This ranges from initial pilot studies to advanced safety evaluations.
Animal models:
- Rodents: Mice, rats, guinea pigs, hamsters, and rabbits
- Non-rodents: Dogs and Göttingen Minipigs
Routes of administration:
- Standard routes: Oral (via gavage or using capsules/tablets), dermal, intramuscular, subcutaneous, and intravenous
- Non-standard routes: Topical to the eye, intravitreal, intraperitoneal, and rectal
Analytical Solutions
We provide a comprehensive suite of analytical services to ensure the safety of drug candidates before progressing to first-in-human trials. These include standard toxicological readouts, specialty tests, and custom solutions for bioanalysis and drug formulation analysis.
Comprehensive Engagement
Personal Contact
Our toxicology experts are actively involved from the first initial contact. They provide support and guidance throughout the process. They collaborate with the sponsor to design the study outline and ensure all parties are aligned during a handover meeting. Our study directors serve as the main point of contact. They keep the sponsor informed about the study’s progress.
On-Time Reporting
Scantox is committed to delivering high-quality scientific data and reports to our clients. We have a strong track record of on-time reporting. Any delays or errors are promptly addressed with the client to find the best solution.
Robust Data & Sample Management
We use a state-of-the-art laboratory information management system (LIMS). Our laboratories are equipped with sensors to include 24/7 temperature control.
Animal facility
Our regulatory toxicology capabilities cover more than 8,500 m², fully GLP-accredited. We can accommodate housing for 450 non-rodents and have 24 rooms for rodents.
Team
The general toxicology team operates out of the HQ facility in Ejby, Denmark.
The team is supported by Mikkel Lykke Jensen, Chief Scientific Officer of Scantox and comprises highly qualified scientists and animal technicians. They bring decades of experience in conducting successful toxicology studies. Each member of our technical staff is skilled in animal handling and dosing. They ensure the highest standards of care and precision in all studies.
Choosing Scantox means you partner with scientific experts. Our team offers tailored solutions thanks to our deep scientific expertise and flexible service model. We have established proven processes to meet your specific project deadlines. Our toxicology team’s very low turnover rate ensures consistent and reliable performance.
Mikkel Lykke Jensen
Mikkel Lykke Jensen has 15 years of experience within Life Science. Prior to joining Scantox, he worked in academia with animal models to study human pediatric nutrition and malnutrition. He has held several positions in Scantox and is now responsible for scientific development as well as animal welfare. Mikkel is a member of the Danish Animal Experiment Council where he has been appointed by Danish Industry.
Frequently Asked Questions
Key considerations include:
- Clinical Program Alignment: What is the intended clinical use – route of administration, frequency and duration of the treatment? Intended age group. Are there any special investigations in the clinical program that should be included in the non-clinical program? e.g. biomarkers.
- Regulatory Compliance: Is the drug product prepared for testing according to Good Laboratory Practice (GLP) standards? Is a certificate of analysis available to confirm quality and are stability data available?
- Strategic Planning: When will the test item be available? What is the timetable for animal testing and the availability of data for discussions with the regulatory authorities?
Detecting severe toxicity can risk animal health and disrupt the study. However, observing mild toxicity is valuable as it provides insights into the drug’s safety profile. It helps to identify effects on clinical and pathology parameters, setting the No Observed Adverse Effect Level (NOAEL) which defines safe dosage limits.
General toxicology studies are essential for IND-enabling programs supporting FIH studies. They are designed to match the intended duration of clinical studies or potential human exposure and will guide how the clinical dose is selected.
Ready to start?
Contact us if you are interested in discussing how to get your study started.