Biosimilar Drug Product Development

This book PDF is perfect for those who love Medical genre, written by Laszlo Endrenyi and published by CRC Press which was released on 24 February 2017 with total hardcover pages 477. You could read this book directly on your devices with pdf, epub and kindle format, check detail and related Biosimilar Drug Product Development books below.

Biosimilar Drug Product Development
Biosimilar Drug Product Development
Author : Laszlo Endrenyi
File Size : 42,7 Mb
Publisher : CRC Press
Language : English
Release Date : 24 February 2017
ISBN : 9781498718806
Pages : 477 pages
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Biosimilar Drug Product Development by Laszlo Endrenyi Book PDF Summary

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Biosimilar Drug Product Development

Biosimilar Drug Product Development by Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed

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Methodologies in Biosimilar Product Development

Methodologies in Biosimilar Product Development by Sang Joon Lee,Shein-Chung Chow

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)

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Biosimilars

Biosimilars by Hiten J. Gutka,Harry Yang,Shefali Kakar

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule,

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Biologics and Biosimilars

Biologics and Biosimilars by Xiaodong Feng,Hong-Guang Xie,Ashim Malhotra,Catherine F. Yang

Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety,

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Biosimilars of Monoclonal Antibodies

Biosimilars of Monoclonal Antibodies by Cheng Liu,K. John Morrow, Jr.

Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts,

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Introduction to Biologic and Biosimilar Product Development and Analysis

Introduction to Biologic and Biosimilar Product Development and Analysis by Karen Nagel

The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product

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Biosimilar Clinical Development Scientific Considerations and New Methodologies

Biosimilar Clinical Development Scientific Considerations and New Methodologies by Kerry B. Barker,Sandeep M. Menon,Ralph B. D'Agostino, Sr.,Siyan Xu,Bo Jin, PhD

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

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Introduction to Biologic and Biosimilar Product Development and Analysis

Introduction to Biologic and Biosimilar Product Development and Analysis by Karen M. Nagel

The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product

Get Book