Biosimilarity: the fda perspective
Auteur :
Niazi, Sarfaraz K.
Éditeur :
Taylor & Francis Inc
ISBN :
9781498750394
Date de publication :
25 juil. 2018
Dimensions :
25,4 x 17,8 cm
Poids :
1080 g
Langue :
Anglais
Pays d'origine :
USA
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.