Type 1
Studies to investigate mechanism
Knowledge-based Resolution
When a nonclinical safety issue can be explained through published evidence and prior cases, findings are delivered as an expert report.
The Center for Non-clinical Development identifies nonclinical safety issues affecting drug candidates and, when needed, provides solutions through hypothesis-driven studies and integrated multidisciplinary interpretation.
Risk-management
strategy
strategy
Study execution
Results analysis
Toxicity issue resolution
Development Go/No-Go decision
Integration into the overview document
Type 2
Resolution using existing evidence
(experience, knowledge and literature)
(experience, knowledge and literature)
Additional Testing
When additional assays are required to characterize a nonclinical safety issue, appropriate methods are applied to investigate and resolve it.
Type 3
Hypothesis-driven study
to investigate the MoA
to investigate the MoA
New Hypothesis & Study Design
A new hypothesis is developed and tested to characterize and resolve the nonclinical safety issue.
Available Services
- Exploratory toxicity assessment in rodent and non-rodent species
- Provision of GEM (Genetically Engineered Mouse) models
- PK-PD modeling and simulation
- Bioimaging
- Metabolomics-based toxicity assessment
- 3D organoid and mini-organ-based toxicity assessment
- Cross-species comparative metabolomics and selection of appropriate toxicity-test species
- On- and off-target liability assessment using GEM models
- Experimental and toxicologic pathology evaluation and reporting
- Review of GLP and non-GLP reports
- Response strategy and documentation for requests from MFDS, US FDA, PMDA, EMA, NMPA and other regulatory authorities
- Monitoring of CRO-conducted GLP studies
- Analysis and interpretation of toxicology report data
- Preparation of IND packages, including IND/CTD documentation and clinical protocols
