Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development Gutka Hiten J.Pevná vazba
Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape.- Biosimilars 101 - An Introduction to Biosimilars.- Innovation, Patents and Biologics: The Road to…
Specifikacia Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development Gutka Hiten J.Pevná vazba
Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape.- Biosimilars 101 - An Introduction to Biosimilars.- Innovation, Patents and Biologics: The Road to Biosimilar Competition.- Factors influencing investment, business decisions and marketing of biosimilars.- The Changing US Reimbursement Landscape and Biosimilars.- Litigation-Related Issues Under The Biologics Price Competition and Innovation Act.- Section II: Target Product Profile, QbD, CMC, Biosimilar manufacture platform technologies.- Design and implementation of successful regulatory strategies in biosimilar development.- Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges.- EU Perspective on Biosimilars.- Section III: Pharmaceutical development of Biosimilars; analytical