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Aggiungi al carrelloTaschenbuch. Condizione: Neu. Non-Biological Complex Drugs | The Science and the Regulatory Landscape | Daan J. A. Crommelin (u. a.) | Taschenbuch | AAPS Advances in the Pharmaceutical Sciences Series | ix | Englisch | 2016 | Springer | EAN 9783319358512 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
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Aggiungi al carrelloHardcover. Condizione: Brand New. 2015 edition. 400 pages. 9.25x6.25x1.00 inches. In Stock.
Lingua: Inglese
Editore: Springer International Publishing, Springer Nature Switzerland, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Da: AHA-BUCH GmbH, Einbeck, Germania
EUR 117,69
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Aggiungi al carrelloBuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.
Da: AHA-BUCH GmbH, Einbeck, Germania
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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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Aggiungi al carrelloPaperback. Condizione: Like New. LIKE NEW. SHIPS FROM MULTIPLE LOCATIONS. book.
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Da: Brook Bookstore On Demand, Napoli, NA, Italia
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Aggiungi al carrelloCondizione: new. Questo è un articolo print on demand.
Lingua: Inglese
Editore: Springer International Publishing, Springer Nature Switzerland Okt 2016, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germania
EUR 117,69
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 400 pp. Englisch.
Lingua: Inglese
Editore: Springer International Publishing, Springer Nature Switzerland Jul 2015, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germania
EUR 117,69
Quantità: 2 disponibili
Aggiungi al carrelloBuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 400 pp. Englisch.
Lingua: Inglese
Editore: Springer International Publishing, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Da: moluna, Greven, Germania
EUR 101,04
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Aggiungi al carrelloCondizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Discusses the challenges of developing NBCDs, recognizing the special position of these products in the regulatory landscapeReviews analytical tools, pharmacology and PK/PDValuable resource for originator drug manufacturers, generic compani.
Lingua: Inglese
Editore: Springer International Publishing, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Da: moluna, Greven, Germania
EUR 101,04
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Aggiungi al carrelloGebunden. Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Discusses the challenges of developing NBCDs, recognizing the special position of these products in the regulatory landscapeReviews analytical tools, pharmacology and PK/PDValuable resource for originator drug manufacturers, generic compani.
Da: Majestic Books, Hounslow, Regno Unito
EUR 154,11
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Aggiungi al carrelloCondizione: New. Print on Demand pp. 399.
Da: Biblios, Frankfurt am main, HESSE, Germania
EUR 152,71
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Aggiungi al carrelloCondizione: New. PRINT ON DEMAND pp. 399.
Da: Majestic Books, Hounslow, Regno Unito
EUR 172,08
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Aggiungi al carrelloCondizione: New. Print on Demand 307.
Lingua: Inglese
Editore: Springer, Springer Okt 2016, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germania
EUR 117,69
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Aggiungi al carrelloTaschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 400 pp. Englisch.
Da: Biblios, Frankfurt am main, HESSE, Germania
EUR 169,28
Quantità: 4 disponibili
Aggiungi al carrelloCondizione: New. PRINT ON DEMAND 307.
Lingua: Inglese
Editore: Springer, Springer Jul 2015, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germania
EUR 117,69
Quantità: 1 disponibili
Aggiungi al carrelloBuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 400 pp. Englisch.