|
| Der Artikel wird am Ende des Bestellprozesses zum Download zur Verfügung gestellt. |
Biosimilars and Interchangeable Biologics
ISBN-13:
9781498743488
Veröffentl:
2018
Seiten:
646
Autor:
Sarfaraz K. Niazi
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
2 - DRM Adobe
Sprache:
Englisch
Beschreibung:
Even very established companies have made mistakes when developing biosimilar products. For example, not appreciating future threats to intellectual property caused a biosimilar product development plan to fail after millions have been spent. Additional pitfalls include not anticipating the next line of improved products, better formulations, delivery systems and the possibility that the dosing and indications can themselves be patented. This two-volume set examines how to choose the right product to develop and how to meander around the legal fireworks and secure a viable commercial presence.
Introduction to Biosimilar and Interchangeable Products. Intellectual Property Issues for Biosimilars. European Regulatory Guidance. EMA-Approved Biosimilars. FDA Regulatory Guidance. ROW Regulatory Guidance. US Commercialization. Global Commercialization. Quality and Lifecycle Management.
Kunden Rezensionen
Mehr zum Thema
Folgen Sie uns auf:
