Abstract

The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations in children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulation Initiative. The goal of this ongoing initiative is to address the issues and concerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration.

Related Keywords

• NIH, NICHD, EXTEMPORANEOUS, NATIONAL INSTITUTE FOR CHILD HEALTH AND HUMAN DEVELOPMENT, CHILDREN, INFANTS, USP, UNITED STATES PHARMACOPEIA, OFF-LABEL, FDA, FDAMA, US FOOD AND DRUG ADMINISTRATION, UNITED KINGDOM, NATIONAL HEALTH SERVICE, REGULATORY AGENCY,

Related Categories

• EXCIPIENTS
• LEGAL
• PEDIATRICS
• PATIENT COMPLIANCE
• DOSAGE FORMS/DRUG CARRIERS