Biosimilarity The FDA Perspective

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. The FDA is quite different from other reg...

Ausführliche Beschreibung

Bibliographische Detailangaben

1. Verfasser:	Niazi, Sarfaraz Khan 1949- (VerfasserIn)
Format:	Elektronisch E-Book
Sprache:	English
Veröffentlicht:	Boca Raton, FL CRC Press [2018]
Ausgabe:	First edition
Schlagworte:	MEDICAL / Pharmacology Drugs / Generic substitution Pharmaceutical biotechnology / United States Pharmaceutical biotechnology Biosimilar Pharmaceuticals Drug Approval Government Regulation United States Government Agencies
Online-Zugang:	URL des Erstveröffentlichers
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