Overview
- 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
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 20)
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Table of contents (12 chapters)
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Front Matter
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Non Biological Complex Drugs
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Front Matter
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Characterization of NBCDs; Analytical Tools to Consider
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Front Matter
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Closely related Complex Drugs
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Front Matter
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Regulatory landscape and outlook
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Front Matter
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Back Matter
Keywords
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.
Editors and Affiliations
About the editors
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.
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
DOI: https://doi.org/10.1007/978-3-319-16241-6
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Springer International Publishing Switzerland 2015
Hardcover ISBN: 978-3-319-16240-9Published: 09 July 2015
Softcover ISBN: 978-3-319-35851-2Published: 22 October 2016
eBook ISBN: 978-3-319-16241-6Published: 24 June 2015
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: IX, 390
Number of Illustrations: 34 b/w illustrations, 57 illustrations in colour