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Safe and Effective Medicines for Children
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Safe and Effective Medicines for Children : Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Book Details

Format Paperback / Softback
ISBN-10 0309225493
ISBN-13 9780309225496
Publisher National Academies Press
Imprint National Academies Press
Country of Manufacture US
Country of Publication GB
Publication Date Oct 13th, 2012
Print length 432 Pages
Weight 724 grams
Dimensions 23.10 x 15.40 x 2.60 cms
Product Classification: Paediatric medicinePharmacology
Ksh 11,700.00
Publisher Out of Stock

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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

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