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General Toxicology

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.

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

Carried out either via techniques like snapshot electrocardiograms (ECG), jacketed telemetry or implantable telemetry. Assessments also include monitoring blood pressure.

Clinical Pathology

Includes clinical chemistry, hematology, coagulation tests, and urinalysis – mirroring routine human medical tests.

Ophthalmoscopy

Includes both direct and indirect ophthalmoscopy, along with the measurement of intraocular pressure if needed. Conducted to detect ocular changes that may indicate immune complex development.

Necropsy & Histopathology

At the end of the study, all major organs are examined through histopathological analysis to identify any microscopic changes or abnormalities.

Safety Pharmacology

Includes CNS reflex testing, comprehensive respiratory function analysis, and extensive cardiovascular telemetry studies.

Pharmacokinetics & Toxicokinetics

Blood samples are collected at the beginning and end of dosing to measure drug exposure. Samples are analyzed using LC-MS/MS, to determine how the drug is absorbed, distributed, metabolized, and excreted.

Bioanalysis & Biomarker Monitoring

Customized bioanalytical solutions can be integrated based on client needs, facilitating the alignment of preclinical results with clinical phase expectations.

Dose Formulation Analysis

Dose formulation analysis ensures the accuracy of the drug concentrations administered to the animals. Dose formulation analysis is performed on a GLP-validated HPLC instrument.

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

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.

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.

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
Cardiovascular Assessments
Carried out either via techniques like snapshot electrocardiograms (ECG), jacketed telemetry or implantable telemetry. Assessments also include monitoring blood pressure.
Ophthalmoscopy
Includes both direct and indirect ophthalmoscopy, along with the measurement of intraocular pressure if needed. Conducted to detect ocular changes that may indicate immune complex development.

IND-Enabling Capabilities

We develop clear customized research programs for small molecule assessment, conduct tailored preclinical studies in line with IND requirements and Good Laboratory Practice (GLP) standards, and provIND-Enabling Capabilitieside high-quality data on time that guides your decisions.
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Bioanalysis

Scantox offers a comprehensive full bioanalytical package of LCMS/MS method development, validation, and sample analysis for both exploratory and regulatory studies. We are experts in LCMS/MS bioanalytical method development and validation for the quantification of small molecules and peptides within a variety of different matrices.
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