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Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series, 20)
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesSeller: Ria Christie Collections, Uxbridge, United Kingdom
Seller rating 5 out of 5 stars
£ 96.88
£ 11.98 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
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Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series, 20)
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesSeller: Ria Christie Collections, Uxbridge, United Kingdom
Seller rating 5 out of 5 stars
£ 96.88
£ 11.98 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketCondition: New. In.
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Condition: As New. Unread book in perfect condition.
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Non-biological Complex Drugs : The Science and the Regulatory Landscape
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesSeller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
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Non-biological Complex Drugs : The Science and the Regulatory Landscape
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesSeller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
£ 107.94
£ 15 shipping
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Add to basketCondition: As New. Unread book in perfect condition.
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Taschenbuch. Condition: 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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Hardcover. Condition: Brand New. 2015 edition. 400 pages. 9.25x6.25x1.00 inches. In Stock.
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Non-Biological Complex Drugs : The Science and the Regulatory Landscape
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, Springer Nature Switzerland, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Taschenbuch. Condition: 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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Non-Biological Complex Drugs : The Science and the Regulatory Landscape
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, Springer Nature Switzerland, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Buch. Condition: 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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Paperback. Condition: Like New. LIKE NEW. SHIPS FROM MULTIPLE LOCATIONS. book.
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Condition: new. Questo è un articolo print on demand.
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Condition: new. Questo è un articolo print on demand.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, Springer Nature Switzerland Okt 2016, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Seller rating 5 out of 5 stars
Taschenbuch. Condition: 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.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, Springer Nature Switzerland Jul 2015, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Seller rating 5 out of 5 stars
Buch. Condition: 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.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Condition: 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.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer International Publishing, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Gebunden. Condition: 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.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer, Springer Okt 2016, 2016
ISBN 10: 3319358510 ISBN 13: 9783319358512
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germany
Seller rating 5 out of 5 stars
Taschenbuch. Condition: 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.
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Non-Biological Complex Drugs
Book 18 of 38: AAPS Advances in the Pharmaceutical SciencesLanguage: English
Published by Springer, Springer Jul 2015, 2015
ISBN 10: 3319162403 ISBN 13: 9783319162409
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germany
Seller rating 5 out of 5 stars
Buch. Condition: 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.
