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.
Acute & Dose-Range Finding Studies
Define the intrinsic drug toxicities and provide data on acute exposure. The process begins with a Maximum Tolerated Dose (MTD) study, followed by a Dose Range Finding (DRF) study. DRF studies typically involve daily dosing over a short period, ranging from seven days to two weeks. They guide the appropriate dose levels for subsequent toxicity studies.
Subchronic & Chronic Studies
Repeat-dose toxicity studies assess the drug’s safety over extended periods. These studies last 28 days (4 weeks). They are essential for the First-in-Human (FIH) studies package. They may be followed by 13-week (3-month) studies for both rodents and non-rodents. For the full chronic studies the rodent studies have a duration of 26-weeks while the non-rodent studies last 39-weeks. This structured approach is key for a full assessment of the compound’s safety.
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.
Cardiovascular Assessments
Clinical Pathology
Ophthalmoscopy
Necropsy & Histopathology
Safety Pharmacology
Pharmacokinetics & Toxicokinetics
Bioanalysis & Biomarker Monitoring
Dose 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.
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.
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.
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