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

• Corporate Author: SpringerLink (Online service)
• Other Authors: Crommelin, Daan J.A (Editor), de Vlieger, Jon S. B. (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Series: AAPS Advances in the Pharmaceutical Sciences Series, 20
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

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...

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.