Intra-AgencyAgreementBetweenthe重点.PDFVIP

Intra-Agency Agreement Between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the U.S. Food and Drug Administration (FDA) Oral Formulations Platform—Report 1 The objective of this work is to provide some baseline information about marketed pediatric products that have been approved for administration to pediatric patients. These products are approved either for administration to pediatric patients as-is or by reconstitution and compounding with specific instructions on the product label. A significant amount can be learned from these approved products, and the knowledge gained can be applied for the development of new formulations of new and existing active pharmaceutical ingredients (APIs). As part of the National Institutes of Health-FDA initiative, a list of 382 products has been compiled so far. This list was compiled based on the approved products listed on the FDA Web site (/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsM enu) or from the Sigler’s Prescription Drug Card list (SFI medical publishing, P.O. Box 3578, Lawrence, KS 66046). A review of the currently available products indicate that the pediatric medications are available as drops, syrups, elixirs, suspensions, sprinkles, capsules, injectables, chewable tablets, orally disintegrating tablets, coated products, metered dose inhalers (MDIs) and dry powder inhalers (DPIs), orally dissolving films, minitabs, and others (e.g., non-oral drops, creams, ointments, etc.). Application of computational methods to categorize the molecules of approved products based on their physicochemical and other properties is currently under way. In this early report, the oral liquid dosage forms, including drops, syrups, elixirs, suspensions, and modified release oral dosage forms, are being discussed. In the development of pediatric as well as adult products, the Biopharmaceutics