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Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports

Author(s):  Haase Mark R, Luedtke Sherry, Robles Janie, Parker Thomas, Leff Rich, Giacoia George

Issue:  Jan/Feb 2009 - Compounding for Pediatrics
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Abstract:  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 insuffi cient information is addressed, replication of many pediatric drug trials is impossible, calling into question their reliability and validity.

Related Keywords: Mark R. Haase, PharmD, BCPS, Sherry Luedtke, PharmD, Janie Robles, PharmD, Thomas Parker, PharmD, Rich Leff, PharmD, George Giacoia, MD, children, dosage forms, clinical drug trials, journals

Related Categories: PEDIATRICS, DOSAGE FORMS/DRUG CARRIERS, INFORMATION RESOURCES

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