Téléchargez le livre : Non-Biological Complex Drugs

Non-Biological Complex Drugs

The Science and the Regulatory Landscape de

,

Éditeur :

Springer


Collection :

AAPS Advances in the Pharmaceutical Sciences Series

Paru le : 2015-06-24

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Description

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.
Pages
390 pages
Collection
AAPS Advances in the Pharmaceutical Sciences Series
Parution
2015-06-24
Marque
Springer
EAN papier
9783319162409
EAN PDF
9783319162416
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
39
Taille du fichier
11540 Ko
Prix
120,99 €
EAN EPUB
9783319162416
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
39
Taille du fichier
7178 Ko
Prix
120,99 €

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