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Non-biological complex drugs [electronic resource] : the science and the regulatory landscape / Daan J.A. Crommelin, Jon S.B. de Vlieger, editors.

Crommelin, D. J. A. (Daan J. A.), editor.; Vlieger, Jon S. B. de, editor.
2015
RS380
Available Online
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Title
Non-biological complex drugs [electronic resource] : the science and the regulatory landscape / Daan J.A. Crommelin, Jon S.B. de Vlieger, editors.
ISBN
9783319162416 electronic book
3319162411 electronic book
9783319162409
Published
Cham : Springer, 2015.
Language
English
Description
1 online resource : illustrations.
Call Number
RS380
Dewey Decimal Classification
615.1/9
Summary
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. .
Bibliography, etc. Note
Includes bibliographical references and index.
Access Note
Access limited to authorized users.
Source of Description
Online resource; title from PDF title page (viewed June 29, 2015).
Added Author
Crommelin, D. J. A. (Daan J. A.), editor.
Added Corporate Author
Vlieger, Jon S. B. de, editor.
Series
AAPS advances in the pharmaceutical sciences series ; v. 20.
Linked Resources
Online Access
Record Appears in
Online Resources > Ebooks
All Resources
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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