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Title Safety efforts in pediatric drug development / Conor D. Byrne, editor
Published New York : Nova Science Publishers, [2010]
Online access available from:
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Description 1 online resource (xiv, 133 pages) : illustrations
Series Pharmacology--research, safety testing and regulation series
Pharmacology-research, safety testing, and regulation series.
Contents FDA's authority to ensure that drugs prescribed to children are safe and effective / Susan Thaul -- 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) -- Pediatric drug research : studies conducted under Best Pharmaceuticals for Children Act / GAO -- Pediatric drug research : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act / GAO
Bibliography Includes bibliographical references and index
Notes Print version record
Subject United States. Best Pharmaceuticals for Children Act.
Drug development -- United States -- Safety measures.
Pediatric pharmacology -- United States.
Pediatrics -- United States -- Formulae, receipts, prescriptions -- Safety measures.
Drug Approval.
Drug Evaluation -- standards.
Drug Toxicity -- prevention & control.
Legislation, Drug.
United States.
Form Electronic book
Author Byrne, Conor D.
LC no. 2009031817
ISBN 161209368X (electronic bk.)
9781612093680 (electronic bk.)