Non-Biological Complex Drugs : The Science and the Regulatory Landscape / edited by Daan J.A. Crommelin, Jon S. B. de Vlieger
Contributor(s): Crommelin, Daan J. A., editor literario
| Vlieger, Jon S. B. de, editor literario
Material type: 
E-bookSeries: AAPS Advances in the Pharmaceutical Sciences Series; 2020Publisher: Cham, Switzerland : Springer, 2015Description: 1 recurso en línea (IX, 390 p.) 91 il., 57 il. col..ISBN: 9783319162416.Subject: Biotecnología farmacéuticaOnline resources: Acceso a este recurso digital (usuarios Universidad Europea de Madrid)
Summary: 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.Â{u036F}reover, 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.Â{uE000}
| Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds | |
|---|---|---|---|---|---|---|---|---|---|
LIBRO-E NO PRÉSTAMO
|
Madrid Digital Acceso Electrónico (UEM) | Ciencias de la Salud | RS380 .N663 2015 EB (Browse shelf(Opens below)) | .i11569360 | Acceso electrónico | eBOOK .i11569360 |
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.Â{u036F}reover, 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.Â{uE000}
There are no comments on this title.