Drug development food-effect assessment

FOOD-EFFECT ASSESSMENT IN DRUG DEVELOPMENT KEY CONSIDERATIONS... 

Safety is a prime concern in the development of pharmaceutical products. A drug that has an excellent therapeutic effect cannot be released to the market if it has serious adverse effects. Extensive pharmacologic studies and strict evaluations of CAs are required before gaining approval from the Food and Drug Administration (FDA). Factors assessed include the formulation, hemodynamic effect, toxicity, adverse effects, viscosity, osmolality, and immunogenicity of the agent [86]. 

Pracon, Incorporated, "Study to Assess Impacts of Releasing Safety and Effectiveness Data on the Pharmaceutical Industry s Incentives to Invest In and Conduct Research and Development Programs", Food and Drug Administration Contract No. 228-77-8052, Vienna, Virginia, 1978. 10... 

The code will be broken and data will be analyzed when the 12-mo follow-up has been completed for all patients. At that time, DHA therapy will be offered to all patients who desire to receive it. Clinical and laboratory studies will be monitored by an independent data and safety monitoring committee. This committee will also perform an interim analysis when 30 patients have completed assessment and has permission to terminate the study if there are significant favorable findings or unanticipated adverse outcomes. A determination of statistical power indicates that this sample size is sufficient to detect a major effect (0.862 standard deviations). With a more modest effect of 25%, however, the statistical power diminishes to 60%. The study has been approved by the Institutional Review Board at the Johns Hopkins Medical Institutions and is supported by a research grant from the Office of Orphan Products Development at the Food and Drug Administration. Fifty-two patients are enrolled in the study at this time. The code has not yet been broken. No adverse effects attributable to the medication have been observed. 

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