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AAPS Advances in the Pharmaceutical Sciences Series

Non-Biological Complex Drugs

The Science and the Regulatory Landscape

Editors: Crommelin, Daan J.A., de Vlieger, Jon S.B. (Eds.)

  • Discusses the challenges of developing NBCDs, recognizing the special position of these products in the regulatory landscape
  • Reviews analytical tools, pharmacology and PK/PD
  • Valuable resource for originator drug manufacturers, generic companies and regulatory agencies
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Buy this book

eBook $129.00
price for USA in USD (gross)
  • ISBN 978-3-319-16241-6
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.99
price for USA in USD
  • ISBN 978-3-319-16240-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $169.99
price for USA in USD
  • ISBN 978-3-319-35851-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests.

This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.

About the authors

Prof. Daan Crommelin is emeritus-professor at the Department of Pharmaceutics at Utrecht University. Until December 2011 he was scientific director of the Dutch Top Institute Pharma in Leiden. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Crommelin is co-founder of OctoPlus, a Leiden based company specialized in the development of pharmaceutical (mainly protein based) product formulations and advanced drug delivery systems. He published extensively and is on the editorial board of 10+ peer reviewed journals in the pharmaceutical sciences.

Dr. Jon de Vlieger, obtained his doctoral degree in bio analytical chemistry from the VU University in Amsterdam. He is currently involved in the strategy department of the Dutch Top Institute Pharma, a not-for-profit organization catalyzing the development of medicines by establishing partnerships and actively managing research programs. For TI Pharma he coordinates several international public private partnerships, including the Non Biological Complex Drugs Working Group, an international network of scientific and clinical experts from academia, industry and regulatory bodies, with expertise in many aspects of the development and evaluation of NBCDs.

Table of contents (12 chapters)

  • Introduction: Defining the Position of Non-Biological Complex Drugs

    Crommelin, Daan J. A. (et al.)

    Pages 1-8

  • Polymeric Micelles

    Gaal, Dr. Ethlinn V.B. (et al.)

    Pages 11-76

  • Liposomes: The Science and the Regulatory Landscape

    Crommelin, Dr. Daan J.A. (et al.)

    Pages 77-106

  • Glatiramoids

    Weinstein, Dr. Vera (et al.)

    Pages 107-148

  • Iron Carbohydrate Complexes: Characteristics and Regulatory Challenges

    Mühlebach, Prof. Stefan (et al.)

    Pages 149-170

Buy this book

eBook $129.00
price for USA in USD (gross)
  • ISBN 978-3-319-16241-6
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.99
price for USA in USD
  • ISBN 978-3-319-16240-9
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $169.99
price for USA in USD
  • ISBN 978-3-319-35851-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Non-Biological Complex Drugs
Book Subtitle
The Science and the Regulatory Landscape
Editors
  • Daan J.A. Crommelin
  • Jon S.B. de Vlieger
Series Title
AAPS Advances in the Pharmaceutical Sciences Series
Series Volume
20
Copyright
2015
Publisher
Springer International Publishing
Copyright Holder
Springer International Publishing Switzerland
eBook ISBN
978-3-319-16241-6
DOI
10.1007/978-3-319-16241-6
Hardcover ISBN
978-3-319-16240-9
Softcover ISBN
978-3-319-35851-2
Series ISSN
2210-7371
Edition Number
1
Number of Pages
IX, 390
Number of Illustrations
34 b/w illustrations, 57 illustrations in colour
Topics