Non-Biological Complex Drugs
The Science and the Regulatory Landscape
Series: AAPS Advances in the Pharmaceutical Sciences Series; 20;
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Product details:
- Edition number Softcover reprint of the original 1st ed. 2015
- Publisher Springer International Publishing
- Date of Publication 22 October 2016
- Number of Volumes 1 pieces, Previously published in hardcover
- ISBN 9783319358512
- Binding Paperback
- See also 9783319162409
- No. of pages390 pages
- Size 235x155 mm
- Weight 6029 g
- Language English
- Illustrations IX, 390 p. 91 illus., 57 illus. in color. Illustrations, black & white 0
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Long description:
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.
MoreTable of Contents:
Introduction: Defining the position of Non-Biological Complex Drugs.- Polymeric micelles.- Liposomes: the science and the regulatory landscape.- Glatiramoids.- Iron carbohydrate complexes: characteristics and regulatory challenges.- Drug Nanocrystals.- Analytical methods for determining the size (distribution) in parenternal dispersions.- NBCD Pharmacokinetics and Bioanalytical Methods to Measure Drug Release.- Low Molecular Weight Heparins, Biological Drugs close to Non-Biological Complex Drugs.- Nanoparticle Albumin-Bound Anticancer Agents.- The EU regulatory landscape of Non-Biological Complex Drugs.- What did we learn? What can we expect in the future? Concluding remarks and outstanding issues.
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