We provide our own proven methodologies, expertise, and accountability to execute nonclinical testing services in the following areas:
- Nonclinical strategy and study design (in vitro studies [e.g., dissolution], pharmacology, pharmacokinetics and toxicology)
- CRO qualification, selection and ongoing management
- Pharmacokinetic analysis and modeling
- Study monitoring, including onsite observations and raw data review
- Detailed review of draft report and conclusions, including NOAEL determination
- Study report finalization
- Project management
If your product is a 505(b)(2), it’s important to note some distinctions in nonclinical development strategy between 505(b)(2) and traditional development programs.
- Public data may be used in lieu of novel trial data, making numerous nonclinical studies, and safety and efficacy tests may not be necessary to achieve 505(b)(2) approval.
- Because 505(b)(2) candidates often have known safety profiles and previous demonstrations of efficacy, risk is diminished, increasing investment appeal.
- 505(b)(2) often allows nonclinical and clinical studies to be completed in parallel, abridging the process of drug development even further.
Awareness of published literature, existing risk-benefit profiles and opportunities to run parallel studies are critical to building and executing a robust nonclinical program and services, to reduce short- and long-term costs.