Safety Studies
Identifying potential safety risks early is essential for selecting the right candidate, optimizing dose selection, and reducing development risk before regulatory toxicology studies. Exploratory safety assessments provide critical insights into tolerability, pharmacology, and target-related effects, enabling informed decisions while conserving valuable time and resources.
At Transpharmation, we specialize in non-GLP, translational safety studies designed to support early drug development. By combining safety assessments with pharmacokinetic, pharmacodynamic, and disease model expertise, we help sponsors understand the relationship between drug exposure, efficacy, and safety. Our capabilities include specialized large animal models, complex dosing techniques, and route-specific safety evaluations, providing decision-enabling data that guide progression toward formal GLP studies with greater confidence.
Safety study capabilities
- Primary ICH S7A CNS Core Battery
- Supplemental CNS Safety Assessments
- Rodent Seizure Liability Assessment
- Maximum Tolerated Dose (MTD) Studies
- Dose Escalation and Acute Tolerability Studies
- Repeat-Dose Tolerability Studies
- Integrated PK/Safety Studies
- Drug–Drug Interaction Studies
- Exploratory Toxicology
- Pharmacokinetic (PK) Studies
- Local Tolerability Assessments
Endpoints & assessments
- Clinical observations and adverse event monitoring
- Mortality and morbidity assessment
- Clinical signs and neurological observations
- Functional observational battery and behavioral assessment
- Body weight, food consumption, and clinical condition
- Clinical pathology (hematology, clinical chemistry, urinalysis)
- PK/exposure–safety relationships
- Translational biomarker analysis
- Local tolerability and administration site evaluation
- Histopathology and organ weight assessment (where applicable)
Applicable Portfolio Services
Have a program in mind?
Reducing uncertainty early in drug development leads to better decisions later. Through integrated safety assessments, PK, and customized study design, Transpharmation helps sponsors identify potential safety liabilities, dose selection, and confidently advance the most promising therapeutic candidates. Whether you need early tolerability assessments, CNS safety evaluation, or integrated PK/safety studies, our scientists work alongside you to design studies tailored to your development program. Talk to a researcher today to discuss your project and discover how Transpharmation can help move your program forward with confidence.