Safety pharmacology forms the foundation of responsible and effective drug development. These studies evaluate the potential effects of a drug candidate on critical organ systems, including the cardiovascular, respiratory, and central nervous systems. By identifying safety concerns early in development, safety pharmacology studies help reduce patient risk and support the delivery of safe and efficacious therapies.
Our experienced scientific team conducts safety pharmacology studies in full compliance with international regulatory guidelines. All studies are designed to meet global regulatory expectations and support a seamless transition from preclinical development to first-in-human clinical trials.
Our safety pharmacology services are designed to support complex drug development programs through scientifically robust and regulatory-aligned study designs. Extensive experience with both standalone and integrated repeat-dose approaches allows us to efficiently generate meaningful safety data while conserving time and resources.
We perform advanced in vitro assays to evaluate the pharmacological effects of drug candidates at the cellular level. These studies include comprehensive cardiac ion channel assessments—such as sodium, calcium, potassium, and human Ether-à-go-go-Related Gene channels—to identify potential cardiac risks early in development.
Our in vivo safety pharmacology studies assess drug effects in relevant animal models, focusing on vital systems such as the cardiovascular, respiratory, and central nervous systems. We employ modern technologies, including implanted and jacketed external telemetry systems, to enable continuous monitoring of electrocardiographic and hemodynamic parameters in large animal models.
To improve efficiency, safety pharmacology endpoints are often integrated into general toxicology studies when scientifically appropriate. These integrated designs reduce study timelines and resource use while maintaining data integrity. Our teams carefully ensure that safety pharmacology assessments do not interfere with the interpretation of general toxicology outcomes.
We offer fully compliant Good Laboratory Practice studies, ensuring high-quality, reliable data suitable for regulatory submissions worldwide.
Every drug development program is unique. Our safety pharmacology strategies are tailored to meet specific project requirements, ranging from non-Good Laboratory Practice screening assays to full Good Laboratory Practice study designs. We support both small-molecule and large-molecule programs with flexible, science-driven solutions.
Safety pharmacology evaluations support early-phase drug development by helping to:
International regulatory guidelines require a core battery of safety pharmacology assessments before initiating first-in-human dosing. These studies focus on the cardiovascular, central nervous, and respiratory systems, with supplemental evaluations added when scientifically justified.
Our integrated approach combines in vitro and in vivo assessments to provide a comprehensive understanding of system-level effects and potential risks. This strategy supports informed decision-making throughout preclinical development.
Supplemental evaluations, such as gastrointestinal motility and irritation studies, are conducted when required to address compound-specific risks.
When appropriate, cardiovascular and respiratory assessments are combined in surgically implanted non-rodent models using telemetry. This approach allows evaluation of time-dependent effects, supports mechanistic insights, reduces animal use in line with the principles of Replacement, Reduction, and Refinement, and lowers overall study costs.