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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.

Get Nonclinical Expertise Now

To learn how you can benefit from our nonclinical expertise, Contact Us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
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