|
| Der Artikel wird am Ende des Bestellprozesses zum Download zur Verfügung gestellt. |
Biosimilarity
Beschreibung:
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.
Current Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation
Kunden Rezensionen
Mehr zum Thema
Folgen Sie uns auf:
