| Main Title |
Non-Biological Complex Drugs The Science and the Regulatory Landscape / [electronic resource] : |
| Type |
EBOOK |
| Other Authors |
|
| Publisher |
Springer International Publishing : Imprint: Springer, |
| Year Published |
2015 |
| Call Number |
RS380; RS190-210 |
| ISBN |
9783319162416 |
| Subjects |
Medicine ;
Pharmaceutical technology
|
| Internet Access |
|
| Collation |
IX, 390 p. 91 illus., 57 illus. in color. online resource. |
| Notes |
Due to license restrictions, this resource is available to EPA employees and authorized contractors only |
| Contents Notes |
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. 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. . |
| Place Published |
Cham |
| Corporate Au Added Ent |
SpringerLink (Online service) |
| Title Ser Add Ent |
AAPS Advances in the Pharmaceutical Sciences Series, 20 |
| Host Item Entry |
Springer eBooks |
| PUB Date Free Form |
2015 |
| Series Title Untraced |
AAPS Advances in the Pharmaceutical Sciences Series, 20 |
| BIB Level |
m |
| Medium |
computer |
| Content |
text |
| Carrier |
online resource |
| Cataloging Source |
OCLC/T |
| OCLC Time Stamp |
20150626022929 |
| Language |
eng |
| Origin |
SPRINGER |
| Type |
EBOOK |
| OCLC Rec Leader |
03302nam a22004455i 45 |
