Successful FDA Meeting Advances Botanical Drug to Phase II Study
Germantown, MD, USA (October 08, 2013) – Amarex Clinical Research recently met with the FDA on behalf of their client to propose a PII study as the next step of their clinical development program.(October 08, 2013) – Amarex Clinical Research recently met with the FDA on behalf of their client to propose a PII study as the next step of their clinical development program.
Significantly, prior research was all conducted outside the US and included minimal pre-clinical assays and one small PI trial. The FDA agreed to a PII design which combines additional safety testing and dose finding in patients before adapting to a more traditional PII study with an emphasis on efficacy testing. The investigational product is derived from a plant and will be used to treat an orphan indication.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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