Record Display for the EPA National Library Catalog


OLS Field Name OLS Field Data
Main Title Non-Biological Complex Drugs The Science and the Regulatory Landscape / [electronic resource] :
Other Authors
Author Title of a Work
Crommelin, Daan J.A.
de Vlieger, Jon S. B.
Publisher Springer International Publishing : Imprint: Springer,
Year Published 2015
Call Number RS380; RS190-210
ISBN 9783319162416
Subjects Medicine. ; Pharmaceutical technology.
Internet Access
Description Access URL
Collation IX, 390 p. 91 illus., 57 illus. in color. online resource.
Due to license restrictions, this resource is available to EPA employees and authorized contractors only
Contents Notes
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. 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. .