Non-Biological Complex Drugs / AAPS Advances in the Pharmaceutical Sciences Series Bd.20 (PDF)
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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.
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.
- 2015, 2015, 390 Seiten, Englisch
- Herausgegeben: Daan J. A. Crommelin, Jon S. B. de Vlieger
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3319162411
- ISBN-13: 9783319162416
- Erscheinungsdatum: 24.06.2015
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