Drug Safety - Safety Pharmacology & Toxicology
The TRN drug safety team provide access to a range of service providers and consultants to deliver support in the following areas:
Safety Pharmacology
- Design and management of GLP-compliant safety pharmacology and supplemental safety pharmacology studies.
- Advice on potential target/mechanism related and compound safety pharmacology liabilities.
- Access to and interpretation of broad ligand profiling panels for assessing the potential to cause off-target effects
- CRO selection. Protocol design, study oversight, report review and subject matter expertise for outsourced studies.
- Preparation of regulatory documents
- Extrapolation of safety pharmacology findings to man and assessment of risk/benefit.
- See our safety pharmacology flyer
Toxicology:
- Design and management of toxicology studies including GLP compliance oversight.
- Investigative / supplemental toxicology tests.
- CRO selection. Protocol design, study oversight, report review and broad subject matter expertise for outsourced studies.
- Preparation of regulatory documents
- Extrapolation of toxicology findings to man and assessment of risk/benefit.
Pathology
- Toxicologic Pathology (study design, protocol review, study monitoring and necropsy supervision)
- Pathology peer review and primary interpretation of gross, microscopic, and clinical pathology data from toxicology studies.
- Toxicological risk assessment and interaction with government regulatory authorities.
- See our toxicology & pathology flyer
Meet the drug safety team
