Safety Pharmacology/
De-risking Early Development
Our safety pharmacology studies are designed to identify potential functional safety risks early by evaluating effects of test articles on vital physiological systems. This enables informed candidate selection, supports dose escalation decisions, and aligns with regulatory expectations during preclinical development.
Comprehensive core and follow-up assessments across:
- Cardiovascular
- Respiratory
- Central Nervous System (CNS)
- Gastrointestinal function
- Renal function
Our Capabilities Include:
- In vitro hERG assay (HEK cells) to assess cardiac ion channel liability.
- In vivo cardiovascular telemetry in dogs for real-time heart rate, blood pressure, and ECG monitoring.
- Pulmonary function testing in rats.
- Modified Irwin (FOB) assessments for neurobehavioral evaluation.
- Gastrointestinal motility studies in rats.
- Renal functional studies in rats.
- In vitro hERG assay (CHO/HEK)
- Pulmonary function in rats
- Modified Irwin test (FOB) in rats
- Cardiovascular telemetry in dogs
- Gastrointestinal motility in rats
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your safety pharmacology studies and IND-enabling programs.
what people ask
Frequently Asked Questions
How relevant are gastrointestinal motility studies during early safety assessment?
Gastrointestinal motility studies are particularly relevant for orally administered compounds and help identify potential GI functional effects that may impact tolerability or dosing strategies.
Can safety pharmacology studies be conducted as standalone or integrated studies?
Safety pharmacology assessments can be conducted either as standalone studies or integrated into toxicology study designs, depending on the development stage and regulatory strategy.
Are study designs flexible across different therapeutic areas?
Yes. Study designs and selected endpoints can be tailored based on the therapeutic target, route of administration, and anticipated clinical exposure profile.
Can safety pharmacology studies be used to support IND‑enabling programs?
Yes. Safety pharmacology data are a key component of IND‑enabling packages and help address regulatory expectations for cardiovascular, respiratory, CNS, gastrointestinal and renal safety.
Are these studies suitable for regulatory submissions?
Yes. Our safety pharmacology studies are designed in line with applicable regulatory guidelines and are suitable to support regulatory interactions and preclinical safety packages.
