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Safety Efforts in Pediatric Drug Development
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Editors: Conor D. Byrne
Book Description:
This book focuses on the safety efforts being implemented in pediatric drug development. Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only about one-third of the drugs that are prescribed for children have been studied and labeled for pediatric use. This has placed children taking drugs for which there have not been adequate pediatric drug studies at risk of being exposed to ineffective treatment or receiving incorrect dosing. In order to encourage the study of more drugs for pediatric use, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to provide marketing incentives to drug manufacturers for conducting pediatric drug studies. Drug manufacturers may obtain six months of additional market exclusivity for drugs on which they have conducted pediatric studies in accordance with pertinent law and regulations. This book also evaluates the impact of BPCA on labeling drugs for pediatric use and the process by which the labeling was changed, and illustrates the range of diseases treated by the drugs studied under BPCA. Additionally this book provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing.

This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.

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Table of Contents:

FDA's Authority to Ensure that Drugs Prescribed to Children Are Safe and Effective (Susan Thaul), pp. 1-30

Guidance for Industry Nonclinical Safety Evaluation of Pediatric Drug Products (U.S. Dept. of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), pp. 31-58

Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act (GAO), pp. 59-108

Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act (GAO), pp. 109-124

Index, pp. 125

      Pharmacology - Research, Safety Testing and Regulation
   Binding: Hardcover
   Pub. Date: 2010 1st Quarter
   ISBN: 978-1-60741-565-7
   Status: AV
Status Code Description
AN Announcing
FM Formatting
PP Page Proofs
FP Final Production
EP Editorial Production
PR At Prepress
AP At Press
AV Available
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03.Chronic Disease and Disability: The Pediatric Lung
04.Fruit and Vegetable Consumption and Health: New Research
05.Fire and the Sword: Understanding the Impact and Challenge of Organized Islamism. Volume 2

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Safety Efforts in Pediatric Drug Development