Africa largest book store
By: (Edited by) Sang Joon Lee , (Edited by) Shein-Chung Chow
Werezi Extended Catalogue
Delivery in 34 days
Delivery fee
Delivery in 34 days
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval.
Key Features:
This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.
Get Methodologies in Biosimilar Product Development by at the best price and quality guranteed only at Werezi Africa largest book ecommerce store. The book was published by Taylor & Francis Ltd and it has pages. Enjoy Shopping Best Offers & Deals on books Online from Werezi - Receive at your doorstep - Fast Delivery - Secure mode of Payment
