Analytical similarity assessment in biosimilar product development
Auteur :
Chow, Shein-Chung
Éditeur :
Taylor & Francis Ltd
ISBN :
9781138307339
Date de publication :
1 août 2018
Dimensions :
23,4 x 15,6 cm
Poids :
646 g
Langue :
Anglais
Pays d'origine :
Grande Bretagne
Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment.