Author:
Publisher:
ISBN:
Category : European communities
Languages : en
Pages : 1012

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Author: William Swan Sonnenschein
Publisher:
ISBN:
Category : Best books
Languages : en
Pages : 880

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Author: Mary E. Lassanyi
Publisher:
ISBN:
Category : Agriculture
Languages : en
Pages : 32

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Author:
Publisher:
ISBN: 9789071239038
Category :
Languages : en
Pages :

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Author:
Publisher:
ISBN:
Category : Engineering
Languages : en
Pages : 1196

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Author:
Publisher:
ISBN:
Category : Photoengraving
Languages : en
Pages : 316

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Author: Hiten J. Gutka
Publisher: Springer
ISBN: 3319996800
Category : Medical
Languages : en
Pages : 709

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Book Description
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Author:
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ISBN:
Category : Electric industries
Languages : en
Pages : 660

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Author:
Publisher:
ISBN:
Category : English newspapers
Languages : en
Pages : 468

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Author: Paul J.J. Welfens
Publisher: Springer Science & Business Media
ISBN: 3642799698
Category : Business & Economics
Languages : en
Pages : 399

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Book Description
EU monetary integration was reinforced in the 1980s when macroeconomic convergence and a dominant role of the German Bundesbank created the basis for relatively stable exchange rates and increasing EU trade volumes. The analysis here focuses on the EMS crisis of 1992/93, the topic of optimum currency areas and the problem of fiscal policies and regional stabilization in Europe, the US and Canada. This book gives an assessment of the EMS developments and shows how financial market liberalization as well as the EU single market project affect the process of economic and monetary union. The role of currency substitution and problems of the Bundesbank's monetary policy control in a changing international system are evaluated.