What steps are involved to develop a DHA product specifically for CF patients?
Development of any new medication requires testing in laboratory animals before patients. The FDA requires that a safe and optimal dose be determined in small initial trials (Phase I and Phase II). Full proof that the drug actually helps patients must be established in much larger trials (Phase III) that will involve all CF Foundation-accredited care centers. Plans are underway to evaluate a modified DHA formulation for CF patients in clinical trials expected to begin in the year 2000.