Coverart for item
The Resource Non-Biological Complex Drugs : The Science and the Regulatory Landscape, edited by Daan J.A. Crommelin, Jon S. B. de Vlieger, (electronic resource)

Non-Biological Complex Drugs : The Science and the Regulatory Landscape, edited by Daan J.A. Crommelin, Jon S. B. de Vlieger, (electronic resource)

Label
Non-Biological Complex Drugs : The Science and the Regulatory Landscape
Title
Non-Biological Complex Drugs
Title remainder
The Science and the Regulatory Landscape
Statement of responsibility
edited by Daan J.A. Crommelin, Jon S. B. de Vlieger
Contributor
Subject
Language
eng
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. 
Member of
Is part of
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Crommelin, Daan J.A
  • de Vlieger, Jon S. B
  • SpringerLink (Online service)
Series statement
AAPS Advances in the Pharmaceutical Sciences Series,
Series volume
20
http://library.link/vocab/subjectName
  • Medicine
  • Pharmaceutical technology
Label
Non-Biological Complex Drugs : The Science and the Regulatory Landscape, edited by Daan J.A. Crommelin, Jon S. B. de Vlieger, (electronic resource)
Instantiates
Publication
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
Control code
ssj0001525243
Dimensions
unknown
Extent
1 online resource (IX, 390 p. 91 illus., 57 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9783319162409
Isbn Type
(print)
Other control number
10.1007/978-3-319-16241-6
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001525243
Label
Non-Biological Complex Drugs : The Science and the Regulatory Landscape, edited by Daan J.A. Crommelin, Jon S. B. de Vlieger, (electronic resource)
Publication
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
Control code
ssj0001525243
Dimensions
unknown
Extent
1 online resource (IX, 390 p. 91 illus., 57 illus. in color.)
Form of item
online
Governing access note
Access restricted to subscribing institutions
Isbn
9783319162409
Isbn Type
(print)
Other control number
10.1007/978-3-319-16241-6
Other physical details
online resource
Specific material designation
remote
System control number
(WaSeSS)ssj0001525243

Library Locations

    • Ladd LibraryBorrow it
      48 Campus Ave, Lewiston, ME, 04240, US
      44.105245 -70.203443
Processing Feedback ...