Biosimilar Drug Product Development
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Biosimilar Drug Product Development
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Author : Laszlo Endrenyi
language : en
Publisher: CRC Press
Release Date : 2017-02-24
Biosimilar Drug Product Development written by Laszlo Endrenyi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Medical categories.
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.
Biosimilars
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Author : Hiten J. Gutka
language : en
Publisher: Springer
Release Date : 2018-12-13
Biosimilars written by Hiten J. Gutka and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-13 with Medical categories.
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.
Methodologies In Biosimilar Product Development
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Author : Sang Joon Lee
language : en
Publisher: CRC Press
Release Date : 2021-09-30
Methodologies In Biosimilar Product Development written by Sang Joon Lee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-30 with Mathematics categories.
Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA’s current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time.
Introduction To Biologic And Biosimilar Product Development And Analysis
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Author : Karen Nagel
language : en
Publisher:
Release Date : 2018
Introduction To Biologic And Biosimilar Product Development And Analysis written by Karen Nagel and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with Biologicals categories.
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 Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Analytical Similarity Assessment In Biosimilar Product Development
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Analytical Similarity Assessment In Biosimilar Product Development written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Mathematics categories.
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.
Biologics And Biosimilars
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Author : Xiaodong Feng
language : en
Publisher: CRC Press
Release Date : 2022-06-13
Biologics And Biosimilars written by Xiaodong Feng and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-06-13 with Medical categories.
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, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Biosimilars Of Monoclonal Antibodies
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Author : Cheng Liu
language : en
Publisher: John Wiley & Sons
Release Date : 2016-12-19
Biosimilars Of Monoclonal Antibodies written by Cheng Liu and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-19 with Medical categories.
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
Introduction To Biologic And Biosimilar Product Development And Analysis
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Author : Karen M. Nagel
language : en
Publisher: Springer
Release Date : 2018-09-27
Introduction To Biologic And Biosimilar Product Development And Analysis written by Karen M. Nagel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-27 with Medical categories.
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 Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Biological Drug Products
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Author : Wei Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2013-08-29
Biological Drug Products written by Wei Wang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-29 with Medical categories.
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Biosimilars
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2013-07-29
Biosimilars written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-29 with Mathematics categories.
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.