Biosimilars - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars write by Hiten J. Gutka. This book was released on 2018-12-13. Biosimilars available in PDF, EPUB and Kindle. 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, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Biologics, Biosimilars, and Biobetters
Biologics, Biosimilars, and Biobetters - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biologics, Biosimilars, and Biobetters write by Iqbal Ramzan. This book was released on 2021-02-03. Biologics, Biosimilars, and Biobetters available in PDF, EPUB and Kindle. A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Biosimilars
Biosimilars - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars write by Shein-Chung Chow. This book was released on 2013-07-29. Biosimilars available in PDF, EPUB and Kindle. As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics write by Lisa M.. Plitnick. This book was released on 2015. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics available in PDF, EPUB and Kindle.
Biosimilars of Monoclonal Antibodies
Biosimilars of Monoclonal Antibodies - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars of Monoclonal Antibodies write by Cheng Liu. This book was released on 2016-12-09. Biosimilars of Monoclonal Antibodies available in PDF, EPUB and Kindle. 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, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs
