The Resource Non-biological complex drugs : the science and the regulatory landscape, Daan J.A. Crommelin, Jon S.B. de Vlieger, editors

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

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
Daan J.A. Crommelin, Jon S.B. de Vlieger, editors
Contributor
Editor
Subject
Genre
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
Cataloging source
N$T
Dewey number
615.1/9
Illustrations
illustrations
Index
index present
LC call number
RS380
LC item number
.N65 2015eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
QV 55
http://library.link/vocab/relatedWorkOrContributorName
  • Crommelin, D. J. A.
  • Vlieger, Jon S. B. de
Series statement
AAPS advances in the pharmaceutical sciences series,
Series volume
volume 20
http://library.link/vocab/subjectName
  • Pharmaceutical technology
  • Nanomedicine
  • Bioactive compounds
  • MEDICAL
  • Bioactive compounds
  • Nanomedicine
  • Pharmaceutical technology
  • Biomedicine
  • Pharmaceutical Sciences/Technology
  • Pharmaceutical Preparations
  • Drug Combinations
Label
Non-biological complex drugs : the science and the regulatory landscape, Daan J.A. Crommelin, Jon S.B. de Vlieger, editors
Link
https://ezproxy.lib.ou.edu/login?url=http://link.springer.com/10.1007/978-3-319-16241-6
Instantiates
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Dimensions
unknown
Extent
1 online resource (ix, 390 pages)
File format
unknown
Form of item
online
Governing access note
License restrictions may limit access
Isbn
9783319162416
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Note
SpringerLink
Other control number
10.1007/978-3-319-16241-6
Other physical details
illustrations (chiefly color).
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)911911981
  • (OCoLC)ocn911911981
Label
Non-biological complex drugs : the science and the regulatory landscape, Daan J.A. Crommelin, Jon S.B. de Vlieger, editors
Link
https://ezproxy.lib.ou.edu/login?url=http://link.springer.com/10.1007/978-3-319-16241-6
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Dimensions
unknown
Extent
1 online resource (ix, 390 pages)
File format
unknown
Form of item
online
Governing access note
License restrictions may limit access
Isbn
9783319162416
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Note
SpringerLink
Other control number
10.1007/978-3-319-16241-6
Other physical details
illustrations (chiefly color).
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)911911981
  • (OCoLC)ocn911911981

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