AAPS Advances in the Pharmaceutical Sciences Series

Pediatric Formulations

A Roadmap

Editors: Bar-Shalom, Daniel, Klaus, Rose (Eds.)

  • Provides a comprehensive treatment of pediatric drug development
  • Highlights the anatomical, physiological and developmental differences between adults and children
  • Draws a roadmap to better, innovative formulations, in particular for oral administration
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eBook $149.00
price for USA (gross)
  • ISBN 978-1-4899-8011-3
  • Digitally watermarked, DRM-free
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  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $189.00
price for USA
  • ISBN 978-1-4899-8010-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $189.00
price for USA
  • ISBN 978-1-4939-4521-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

About the authors

Daniel Bar-Shalom is an Associate Professor in Drug Delivery at The Faculty of Health and Medical Sciences, University of Copenhagen. He has a degree in Biology from The Tel-Aviv University (1975), carried research in botany and then graduated from the School of Pharmacy, Hebrew University of Jerusalem (1982). He is a qualified pharmacist and has managed and owned a pharmacy in Haifa where he gained insight into the needs and idiosyncrasies of patients. He moved to Denmark in 1986 and founded Egalet, a drug delivery company where he served until 2007 as Vice President, R&D. He has been a consultant for various pharmaceutical and medical device companies. He is also the inventor of various technologies, holds many patents and has formulated marketed products. His main interests are controlled drug delivery and in particular oral pediatric formulations and geriatric formulations addressing the problem of polypharmacy.

Dr. Klaus Rose is CEO of Klausrose Consulting, Switzerland and advises on pediatric drug development and how to comply with FDA and EMA pediatric requirements. He has studied Latin languages, psychology and medicine. After postgraduate clinical training in general medicine in Germany and England, he joined the pharmaceutical industry. He has held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis from 2001 to 2005 and was Global Head Pediatrics Roche from 2005 to 2009. After a year with a regulatory consultancy, he established his own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development, organizes trainings and publishes on a regular base.

Reviews

From the reviews:

“This book can be useful not only for those in drug development, but also for pharmacists who work in pediatrics (either hospital or community pharmacists), compounding pharmacists, pediatricians, nurses who specialize in this area, and certainly students or residents in any of these disciplines who plan to focus on pediatrics. … I have reviewed and used many books on drug formulations and pharmaceutics, but I have not seen such a complete book devoted specifically to pediatrics.” (Patrick J. McDonnell, Doody’s Book Reviews, July, 2014)

Table of contents (30 chapters)

  • Paediatric Development: Anatomy. Age, Weight, Body Surface and Stature, Organ Development

    Batchelor, Hannah

    Pages 3-7

  • Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics

    Jong, Geert ‘t

    Pages 9-23

  • Developmental Changes in the Processes Governing Oral Drug Absorption

    Koning, Barbara A. E. (et al.)

    Pages 25-42

  • Paediatric Development: Gastrointestinal

    Batchelor, Hannah

    Pages 43-54

  • How to Estimate the Dose to Be Given for the First Time to Pediatric Patients

    Greig, Gerard

    Pages 55-67

Buy this book

eBook $149.00
price for USA (gross)
  • ISBN 978-1-4899-8011-3
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $189.00
price for USA
  • ISBN 978-1-4899-8010-6
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $189.00
price for USA
  • ISBN 978-1-4939-4521-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Pediatric Formulations
Book Subtitle
A Roadmap
Editors
  • Daniel Bar-Shalom
  • Rose Klaus
Series Title
AAPS Advances in the Pharmaceutical Sciences Series
Series Volume
11
Copyright
2014
Publisher
Springer-Verlag New York
Copyright Holder
American Association of Pharmaceutical Scientists
eBook ISBN
978-1-4899-8011-3
DOI
10.1007/978-1-4899-8011-3
Hardcover ISBN
978-1-4899-8010-6
Softcover ISBN
978-1-4939-4521-4
Series ISSN
2210-7371
Edition Number
1
Number of Pages
XV, 439
Number of Illustrations and Tables
40 b/w illustrations, 36 illustrations in colour
Topics