Advancing your drug development program depends on a thorough understanding of the safety profile of your novel drug candidates.
Safety pharmacology studies are an essential part of the non-clinical safety testing required prior to the conduct of human clinical trials for pharmaceuticals.
In the regulatory context, safety pharmacology studies are studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. The main focus is on the effects of the test substance on the function of the vital organ systems (cardiovascular, respiratory and central nervous systems – Core Battery), however, evaluation of other systems may be required (e.g. renal function, gastrointestinal system or immune system) dependent on the properties of the substance in question.
Study Types
Scantox offers the full package of non-clinical core battery safety pharmacology studies, evaluating cardiovascular, respiratory, and central nervous systems. These evaluations are integral to your IND-enabling program, ensuring a smoother transition to first-in-human (FIH) studies.
CNS Safety Assessments
Our Functional Observation Battery (FOB) / modified Irwin test includes evaluation of multiple parameters, providing a comprehensive evaluation of CNS effects.
The test battery includes:
- Cage-Side Observations: Monitoring behavior in the animal’s normal environment (home cage)
- Open-Field Observations: Evaluation of spontaneous behaviour in a novel environment
- Hand-held Observations: Evaluation of reflexes and neurological responses
Our primary animal models for FOB are mice and rats. For the large animals (minipigs and dogs), standardized battery of home cage observations and testing of reflexes and neurological responses are available. To be able to provide the full test battery in large animals as well, we are currently working on implementation of open-field evaluation in minipigs.
Respiratory Safety Evaluations
Whole-body plethysmography is utilized to measure respiratory parameters (rats and mice). Our system accommodates simultaneous measurements of up to sixteen animals.
Only manual quantification of respiration frequency is currently available for large animals. We are working on implementation of automatized quantification of respiration frequency using respiration belts (Jacketed External Telemetry (JET)).
Cardiovascular Safety Studies
Telemetry-based methodology is utilized for evaluation of cardiovascular effects. Dependent on the type of molecule and type of the study, we conduct either non-invasive external telemetry (Jacketed External Telemetry (JET), typically used in general toxicology studies with safety endpoints integrated) or implantable telemetry (typically dedicated stand-alone safety pharmacology studies or as part of MTD/DRF-studies).
Our implementation of the ICH S7A core battery and supplemental testing assessments is complemented by QT interval prolongation studies following the latest ICH S7B/E14 Q&A guidelines.
Our cardiovascular assessments utilize state-of-the-art techniques to monitor heart and vascular health.
External Telemetry (Jacketed Telemetry)
Non-invasive monitoring of heart rate and ECG parameters. Can be combined with minimally invasive (implantation of transmitters) blood pressure.
Implanted Telemetry
Surgical implantation of transmitters to continuously record heart rate, ECG parameters, blood pressure, body temperature, and activity without disturbing the animal.
Additional Safety Studies
Design of additional Safety Studies (second tier studies), addressing specific safety concerns or expected interactions can be individually tailored to the specific needs of your drug candidate.
Safety Pharmacology Studies
In our study designs, we adhere to the International Conference on Harmonization (ICH) guidelines, ensuring that your safety pharmacology studies meet the appropriate regulatory standards. This approach helps ensure regulatory approval and accelerates time to market.
Selecting the appropriate animal model is crucial for generating relevant and translatable data. We align species selection with your general toxicology program, ensuring consistency and reliability.
Frequently Asked Questions
Stand-alone or Integrated with General Toxicology Safety Pharmacology study?
Scantox offers both dedicated stand-alone safety pharmacology studies and an integrated approach by combining safety pharmacology endpoints within general toxicology studies. This flexibility allows us to customize study designs to include specific safety endpoints per Client needs.
With focus on 3R, we undergo discussion with the Client to establish which paradigm would work best for the specific drug development program and whether integration of safety pharmacology endpoints would be a better choice. Our flexible drug candidate-based approach permits resource optimization and time-saving in your drug development process, resulting in better animal welfare, higher efficiency and shorter timelines.
Why Choose Scantox?
- Expertise you can trust: Our team’s deep knowledge of safety pharmacology and general toxicology ensures that your studies are designed and executed to meet the highest scientific and regulatory standards.
- Comprehensive In-House Capabilities: All surgical procedures for telemetry studies are performed in-house, giving us complete control over every step of the process and ensuring consistency across all studies.
- Efficient Operations and Animal Welfare: Our partnership with Ellegaard Göttingen Minipigs A/S ensures rapid delivery of suitable animals, optimizing study timelines and reducing animal stress. We prioritize animal well-being, adhering to the highest standards of care, which enhances the reliability of our data.
- Minipig cardiovascular evaluation: The minipig is an upcoming large animal model in safety pharmacology studies, and we have a lot of experience of using this animal model both in general toxicology and in safety pharmacology studies.
Team
Senior scientists with extensive experience across various species lead our safety pharmacology team. Supported by highly trained technicians proficient in complex procedures and advanced assessments, we are dedicated to delivering reliable scientific data. Our team’s expertise ensures that your studies are conducted with the highest level of professionalism and scientific integrity.
