Review of Pediatric Drug Development: Concepts and Applications
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Review of Pediatric Drug Development: ConceDts and Amlications Tbrrrso Allio, PbD Independent Writer
Corrrspoidracr Address Theresa Allio, PhD. PO Box 5634.TakomaPark,MD 20913 (email: tallio2002 @yahoo.com).
ANDREW E. MULBERG, STEVEN A. SILBER, AND JOHN N.VAN DENANKER,EDS.: PEDZATRlC DRUG DEVELOPMENT: CONCEPTS AND APPLICATIONS. Hoboken. NJ: John Wiley & Sons; 2009. 683 pp., hardcover The passing of the Food and Drug Administration Amendments Act (FDAAA) in 2007 included reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. This legislative act emphasizes that sponsors will need to study drugs in a comprehensive manner in the pediatric population. Pediatric Drug Development: Concepts and Applications is a comprehensive guide to pediatric drug development that should prove useful in determining how to proactively navigate the complicated terrain of pediatric formulation development, clinical study conduct, and nonclinical safety assessments necessary to support these efforts. The book is comprised of 50 chapters covering nine major subjects: the past, present, and future of pediatric drug development: ethical considerations: regulatory guidelines; preclinical safety assessment: pharmacologic principles; clinical trial operations; efficacy and safety endpoints: formulation, chemistry, and manufacturing controls; and case studies of successes. The book also contains an appendix section con-
taining supporting tables and figures. The final product is the cumulative result of 67 authors, representing industry, regulatory agencies, and academia. The ease of reading belies the amount of work that most certainly went into making the text cohesive and clear. Although some repetitiveness exists between chapters, most especially with the history of pediatric legislation, this is found to be a welcome reinforcement and is especially helpful for those new to this topic. Despite the amount of information and the technical nature of its content, the book is an easy read and would be a useful resource for company and program executives,and clinical research, regulatory affairs, toxicology, pharmacology, chemistry, manufacturing, and controls staff. The book does tackle some of the more challenging areas of pediatric drug development. The first several chapters are dedicated to discussing the status of legislation and novel business strategies. These strategies include evaluating a company's portfolio for pediatric development candidates and advancing products through pediatric development in a way that may best align corporate goals and regulatory requirements with serving the unmet needs of pediatric populations. Since corporate structures are not always able to sustain their own pediatric development departments, and since there are a small number of clinicians qualified
DNg Information Journal. Vd.44.pp. 97-99,2010*0092-a615/2010 Rinted in the USA. All rights mewed. C o v g h t dB 2010 h g Information Association. Inc.
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BOOK REVIEW
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