Safety efforts in pediatric drug development
By: [edited by] Conor D. Byrne.
Contributors: Byrne, Conor D.
Publisher: Nova Science Publishers
Published: 2009
Place of publication: Hauppauge, N.Y
Language: eng
ISBN-13: 9781607415657
Subjects: United States; United States; Pediatric pharmacology -- United States; Pediatrics -- United States -- Formulae, receipts, prescriptions -- Safety measures; Drug development -- United States -- Safety measures; Drug Approval -- United States; Child -- United States; Drug Evaluation -- standards -- United States; Drug Toxicity -- prevention & control -- United States; Legislation, Drug -- United States
Notes: Includes index.
Table of contents: title: FDA's authority to ensure that drugs prescribed to children are safe and effective / Susan Thaul; title: 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); title: Pediatric drug research : studies conducted under Best Pharmaceuticals for Children Act / GAO; title: Pediatric drug research : the study and labeling of drugs for pediatric use under the Best Pharmaceuticals for Children Act / GAO.