Biosimilars

The biopharmaceutical global market is a multi-billion-dollar industry.

Master Global Regulations, Biopharma Innovation, and Leadership Skills to Accelerate Your Career

Der Arzneiverordnungs-Report ist seit 1985 eine gemeinsame Publikation von Autoren aus Pharmakologie, Klinik, Praxis, Gesundheitsökonomie und Krankenversicherung. Basis sind die Verordnungsdaten von Arzneimitteln für ambulante Patienten der gesetzlichen Krankenversicherung (GKV). Datenbasis des Jahres 2019 sind 820 Millionen Verordnungen von 179.805 Vertragsärzten und 63.360 Vertragszahnärzten für 73,195 Mio. GKV-Versicherte.

By Kerry B. Barker, Sandeep M. Menon, Ralph B. D'Agostino, Sr., Siyan Xu, Bo Jin, PhD
Represents one of the first books to deal with both statistical and clinical issues in the field
Covers relevant industry challenges surrounding biosimilar studies

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products.

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.