Non-Biological Complex Drugs The Science and the Regulatory Landscape /

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 manufactu...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Crommelin, Daan J.A (Editor ), de Vlieger, Jon S. B. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Colección:AAPS Advances in the Pharmaceutical Sciences Series, 20
Temas:
Pharmaceutical chemistry.
Pharmaceutics.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • 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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