Published by Springer, 2011
ISBN 10: 2817800362 ISBN 13: 9782817800363
Seller: Librairie La Canopee. Inc., Saint-Armand, QC, Canada
Couverture souple. Condition: Neuf. NA5152, 1179B4, 9782817800363.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: booksXpress, Bayonne, NJ, U.S.A.
Soft Cover. Condition: new.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Lucky's Textbooks, Dallas, TX, U.S.A.
Condition: New.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Condition: New.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Ria Christie Collections, Uxbridge, United Kingdom
Condition: New. PRINT ON DEMAND Book; New; Fast Shipping from the UK. No. book.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: GreatBookPricesUK, Castle Donington, DERBY, United Kingdom
Condition: New.
Published by Springer Paris Dez 2014, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the 'generic rule' valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of 'biological medicinal products similar to a biological reference product', or 'biosimilars'. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context. 108 pp. Englisch.
Published by Springer Paris Nov 2012, 2012
ISBN 10: 2817803353 ISBN 13: 9782817803357
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the 'generic rule' valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of 'biological medicinal products similar to a biological reference product', or 'biosimilars'. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context. 108 pp. Englisch.
Published by Springer Verlag, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Revaluation Books, Exeter, United Kingdom
Paperback. Condition: Brand New. 1st edition. 87 pages. 9.00x6.00x0.25 inches. In Stock.
Published by Springer Paris, 2012
ISBN 10: 2817803353 ISBN 13: 9782817803357
Seller: moluna, Greven, Germany
Condition: New.
Published by Springer Paris, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: moluna, Greven, Germany
Condition: New.
Published by Springer Paris, 2012
ISBN 10: 2817803353 ISBN 13: 9782817803357
Seller: AHA-BUCH GmbH, Einbeck, Germany
Buch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the 'generic rule' valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of 'biological medicinal products similar to a biological reference product', or 'biosimilars'. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Published by Springer Paris, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: AHA-BUCH GmbH, Einbeck, Germany
Taschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the 'generic rule' valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of 'biological medicinal products similar to a biological reference product', or 'biosimilars'. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Published by Springer Editions, 2012
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Kennys Bookshop and Art Galleries Ltd., Galway, GY, Ireland
Condition: New. 'Biosimilars' are copies of biological medicinal products no longer protected by certification. Detailing new EU legal and regulatory frameworks on biosimilars, this book also analyzes their safety, marketing, and funding, and includes a section on US rules. Editor(s): Prugnaud, Jean-Louis; Trouvin, Jean-Hugues. Num Pages: 90 pages, 5 black & white tables, biography. BIC Classification: MJCL; MJCM; MJR; MQP; TDCW. Category: (G) General (US: Trade). Dimension: 235 x 155 x 6. Weight in Grams: 180. . 2012. Paperback. . . . .
Published by Springer Editions, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Kennys Bookstore, Olney, MD, U.S.A.
Condition: New. 'Biosimilars' are copies of biological medicinal products no longer protected by certification. Detailing new EU legal and regulatory frameworks on biosimilars, this book also analyzes their safety, marketing, and funding, and includes a section on US rules. Editor(s): Prugnaud, Jean-Louis; Trouvin, Jean-Hugues. Num Pages: 90 pages, 5 black & white tables, biography. BIC Classification: MJCL; MJCM; MJR; MQP; TDCW. Category: (G) General (US: Trade). Dimension: 235 x 155 x 6. Weight in Grams: 180. . 2012. Paperback. . . . . Books ship from the US and Ireland.
Published by Springer, 2012
ISBN 10: 2817803353 ISBN 13: 9782817803357
Seller: Mispah books, Redhill, SURRE, United Kingdom
Hardcover. Condition: Like New. Like New. book.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: GreatBookPricesUK, Castle Donington, DERBY, United Kingdom
Condition: As New. Unread book in perfect condition.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: Mispah books, Redhill, SURRE, United Kingdom
Paperback. Condition: Like New. Like New. book.
Published by Springer, 2014
ISBN 10: 2817805143 ISBN 13: 9782817805146
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Condition: As New. Unread book in perfect condition.