Biosimilars Regulatory, Clinical, and Biopharmaceutical Development /

• Corporate Author: SpringerLink (Online service)
• Other Authors: Gutka, Hiten J. (Editor, http://id.loc.gov/vocabulary/relators/edt), Yang, Harry (Editor, http://id.loc.gov/vocabulary/relators/edt), Kakar, Shefali (Editor, http://id.loc.gov/vocabulary/relators/edt)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2018.
• Edition: 1st ed. 2018.
• Series: AAPS Advances in the Pharmaceutical Sciences Series, 34
• Subjects: Pharmaceutical technology.; Pharmacy.; Pharmaceutical Sciences/Technology.

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the qualit...