Non-Biological Complex Drugs
Produktnummer:
181eae3699b43345a7bf31cb1c20467d8c
| Themengebiete: | Iron carbohydrate complexes Liposomes albumin-cytostatic complexes glatiramoids nanomedicines nanosimilars polymeric micelles regulatory framwork generic drugs and biosimilars |
|---|---|
| Veröffentlichungsdatum: | 09.07.2015 |
| EAN: | 9783319162409 |
| Sprache: | Englisch |
| Seitenzahl: | 390 |
| Produktart: | Gebunden |
| Herausgeber: | Crommelin, Daan J.A. de Vlieger, Jon S. B. |
| Verlag: | Springer International Publishing |
| Untertitel: | The Science and the Regulatory Landscape |
Produktinformationen "Non-Biological Complex Drugs"
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.
Sie möchten lieber vor Ort einkaufen?
Sie haben Fragen zu diesem oder anderen Produkten oder möchten einfach gerne analog im Laden stöbern? Wir sind gerne für Sie da und beraten Sie auch telefonisch.
Juristische Fachbuchhandlung
Georg Blendl
Parcellistraße 5 (Maxburg)
8033 München
Montag - Freitag: 8:15 -18 Uhr
Samstags geschlossen