Home | Amazing | Today | Tags | Publishers | Years | Account | Search 
Analytical Similarity Assessment in Biosimilar Product Development

Buy
Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15.56% of the pharmaceuti cal industry’s gross revenue. Meanwhile, many biological products face losing their patents in the next decade. Attempts have been made therefore to establish an abbreviated regulatory pathway for approval of biosimilar drug products, i.e., follow-on (or subsequently entered) biologics of the innovator’s biologic prod- ucts, in order to reduce cost. However, due to the complexity of the structures of biosimilar products and the nature of the manufacturing process, biological products differ from the traditional small-molecule (chemical) drug products. Although the concepts and principles for bioequivalence and interchangeability could be the same for both chemical generics and biosimilar products, scien tific challenges remain for establishing an abbreviated regulatory pathway for approval of biosimilar products due to their unique characteristics.

This is intended to be the first book entirely devoted to the design and analysis of analytical similarity assessment, including tests for similarity in critical quality attributes at various stages of the biosimilar product develop ment manufacturing process. It covers all of the statistical issues that may occur at various stages of biosimilar product research and development. The goal of this book to provide a useful desk reference and a state-of-the art examination of this subject area to (i) scientists and researchers engaged in pharmaceutical/clinical research and development of biologic products, (ii) those in government regulatory agencies who have to make decisions on the review and approval process of biological regulatory submissions, and (iii) biostatisticians who provide the statistical support to the assessment of analytical similarity of biosimilar products. It is my hope that this book can serve as a bridge between the pharmaceutical/biotechnology industry, gov ernment regulatory agencies, and academia
(HTML tags aren't allowed.)

Interactions Between Computational Intelligence and Mathematics Part 2 (Studies in Computational Intelligence)
Interactions Between Computational Intelligence and Mathematics Part 2 (Studies in Computational Intelligence)

This book presents recent research in the field of interaction between computational intelligence and mathematics. In the current technological age, we face the challenges of tackling very complex problems – in the usual sense, but also in the mathematical and theoretical computer science sense. However, even the most...

Stewarding Sustainability Transformations: An Emerging Theory and Practice of SDG Implementation
Stewarding Sustainability Transformations: An Emerging Theory and Practice of SDG Implementation
In the context of the world’s pressing sustainability challenges this new Report to the Club of Rome presents a novel approach to navigating collaborative change in partnerships between governments, research institutions, corporations and civil society activists. With reference to the 17 Sustainable Development Goals and the Planetary...
Nonlinear Filtering: Methods and Applications
Nonlinear Filtering: Methods and Applications

This book gives readers in-depth know-how on methods of state estimation for nonlinear control systems. It starts with an introduction to dynamic control systems and system states and a brief description of the Kalman filter. In the following chapters, various state estimation techniques for nonlinear systems are discussed, including...


Peacebuilding and Sustainable Human Development: The Pursuit of the Bangsamoro  Right to Self-Determination (The Anthropocene: Politik—Economics—Society—Science)
Peacebuilding and Sustainable Human Development: The Pursuit of the Bangsamoro Right to Self-Determination (The Anthropocene: Politik—Economics—Society—Science)

This book presents the protracted right to self-determination conflict between the Philippine state and the Bangsamoro group in Mindanao, Philippines. In the five decades of attempts to achieve peace, a key element is the Bangsamoros’ search for a kind of development that is compatible with their aspirations for freedom and...

The Wiley Handbook of Global Educational Reform (Wiley Handbooks in Education)
The Wiley Handbook of Global Educational Reform (Wiley Handbooks in Education)

The Wiley Handbook of Global Educational Reform examines educational reform from a global perspective. Comprised of approximately 25 original and specially commissioned essays, which together interrogate educational reform from a critical global and transnational perspective, this volume explores a range of topics and themes...

The Worst Is Yet to Come: A Post-Capitalist Survival Guide
The Worst Is Yet to Come: A Post-Capitalist Survival Guide
Capitalism is about to commit suicide and is threatening to take us down with it. But will it give way to a grand social utopia or the beginning of a new dark age... albeit WiFi enabled?

The Worst is Yet to Come explores the disturbing possibility that the current crisis of neoliberal capitalism isn’t
...
©2019 LearnIT (support@pdfchm.net) - Privacy Policy