Evaluation of dosage form information provided in pediatric drug trial reports
Haase, M.R.; Luedtke, S.; Robles, J.; Parker, T.; Leff, R.; Giacoia, G.
International Journal of Pharmaceutical Compounding 13(1): 14-18
2009
ISSN/ISBN: 1092-4221 PMID: 23969957 Document Number: 634101
This report is the first to replicate the earlier findings of Standing et al and validates the inadequacy of reporting of dosage forms used in pediatric drug trials. Journal authors should provide and journal editors should require adequate dosage form information for published reports of pediatric drug trials. We also recommend that compounding pharmacists provide detailed compounding instructions to assure that extemporaneously compounded formulations can be reliably reproduced, and that quality-control data be provided to support formulation stability. Until the problem of insufficient information is addressed, replication of many pediatric drug trials is impossible, calling into question their reliability and validity.