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Non-biological complex drugsthe scie...

Crommelin, Daan J.A.

Non-biological complex drugsthe science and the regulatory landscape /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Non-biological complex drugsedited by Daan J.A. Crommelin, Jon S. B. de Vlieger.
其他題名:	the science and the regulatory landscape /
其他作者:	Vlieger, Jon S. B. de.
出版者:	Cham :Springer International Publishing :2015.
面頁冊數:	ix, 390 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
標題:	Pharmaceutical technology.
電子資源:	http://dx.doi.org/10.1007/978-3-319-16241-6
ISBN:	9783319162416 (electronic bk.)

Non-biological complex drugsthe science and the regulatory landscape /
Non-biological complex drugsthe science and the regulatory landscape /[electronic resource] :edited by Daan J.A. Crommelin, Jon S. B. de Vlieger. - Cham :Springer International Publishing :2015. - ix, 390 p. :ill., digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,v.202210-7371 ;. - AAPS advances in the pharmaceutical sciences series ;3..

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. .

ISBN: 9783319162416 (electronic bk.)

Standard No.: 10.1007/978-3-319-16241-6doiSubjects--Topical Terms:

237657
Pharmaceutical technology.

LC Class. No.: RS380

Dewey Class. No.: 615.19

Non-biological complex drugsthe science and the regulatory landscape /
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520 $a 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. .
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