rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Non-Biological Complex Drugs
    sub title: The Science and the Regulatory Landscape
  name:
    name part: Crommelin, Daan J.A.
    role:
      role term: editor.
  name:
    name part: de Vlieger, Jon S. B.
    role:
      role term: editor.
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  origin info:
    place:
      place term: gw
    date issued: 2015
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: electronic resource
    reformatting quality: access
    form: remote
    extent: IX, 390 p. 91 illus., 57 illus. in color. online resource.
  abstract: 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. .
  table 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.
  note: edited by Daan J.A. Crommelin, Jon S. B. de Vlieger.
  subject:
    topic: Medicine
  subject:
    topic: Pharmaceutical technology
  subject:
    topic: Biomedicine
  subject:
    topic: Pharmaceutical Sciences/Technology
  classification: RS380
  classification: RS190-210
  classification: 615.19
  related item:
    title info:
      title: Springer eBooks
  related item:
    title info:
      title: AAPS Advances in the Pharmaceutical Sciences Series, 20
  identifier: 9783319162416
  identifier: http://dx.doi.org/10.1007/978-3-319-16241-6
  record info:
    record creation date: 150624
    record change date: 20150626022929.0
    record identifier: 978-3-319-16241-6