منابع مشابه
A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran
We compared the efficacy and safety of a biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of relapsing remitting multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the biosimilar medication and the reference treatment (30 μg intramuscular, weekly for one ...
متن کاملThe Future of Biosimilar Insulins
IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, ...
متن کاملThe process defines the product: what really matters in biosimilar design and production?
Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized...
متن کاملBiosimilar Therapeutic Monoclonal Antibodies
Last month, Part 1 of this discussion brief ly described the regulatory landscape for developing biosimilar therapeutic monoclonal antibodies (TMAbs). We identified certain specific structural components of TMAb drug substances that warrant particular attention because alterations to them are likely to affect therapeutic safety and effectiveness. Now we conclude by considering whether studies o...
متن کاملUnraveling the complexities and nuances of modern Product Lifecycle Management (PLM) solutions
Product lifecycle management (PLM) defines how to manage and automate product lifecycle processes, from product conceptualization to retirement. This paper outlines both the fundamental concepts and the key functional components of a PLM system. It describes key industry imperatives such as virtual product development, product-process-resources methodology, a collaborative PLM, and correspondin...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Journal of Bioanalysis & Biomedicine
سال: 2013
ISSN: 1948-593X
DOI: 10.4172/1948-593x.1000091