ToxStrategies’ professionals have unique and extensive experience in the fields of developmental and reproductive toxicology (DART), and juvenile animal toxicology. With our diverse experience, we can help develop testing strategies to address your product development needs. ToxStrategies scientists provide our clients with protocol development, study oversight, and interpretation of study data, in addition to services that include the following:
DART studies to support pharmaceutical development in adults
- Fit-for-purpose testing strategies to ensure that only studies that provide meaningful data for human risk assessment are conducted
- Craft scientifically justified weight-of-evidence (WOE) arguments to support study waivers
- Use alternative methods when appropriate
- Design and conduct ICH S5(R3) guideline-compliant studies
- Risk management: characterize the impact of study findings on clinical trial conduct and labeling
Nonclinical support for the development of pediatric pharmaceuticals
- Customized strategies to the specific pediatric development program
- Integrated assessment to determine whether a juvenile animal study (JAS) is needed
- If needed, develop a scientifically justified study design consistent with ICH S11 guidance
- Preparation of regulatory documents (e.g., Pediatric Investigative Plan [PIP], initial Pediatric Study Plan [iPSP])
Industrial and environmental chemicals
- Specialized expertise in support of environmental toxicology and REACH
- Support for conduct of OECD guideline developmental and reproductive toxicity studies
- Design of OECD 443 Extended One-Generation Reproductive Toxicity Studies (EOGRTS)
For more information about ToxStrategies’ consulting services, please contact us.