دانلود کتاب بیوژنریک و بیولوژیک تبادل پذیر: از خط سلولی تا راه اندازی تجاری (۲ جلدی) |
Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, 2-Vol, 1ed
What’s the Deal with Biosimilars?
Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.
Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch covers the strategic and tactical elements of biosimilars in two volumes.
The first volume, Biosimilars and Interchangeable Biologics: Strategic Elements, explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.
This volume also examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
The second volume, Biosimilars and Interchangeable Biologics: Tactical Elements, explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.
This volume also provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.
Thus, Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch, Two-Volume Set supplies practitioners, researchers, and scientists in the biopharmaceutical industry with a valuable resource for practical information at all stages of the biosimilar product process.
About the Author
Vol-1: Biosimilars and Interchangeable Biologics: Tactical Elements
Chapter 1: Structural and functional elements
Chapter 2: Immunogenicity considerations
Chapter 3: Product development strategies
Chapter 4: Stability and formulation considerations
Chapter 5: Biosimilarity tetrahedron
Chapter 6: Recombinant expression systems
Chapter 7: Upstream systems optimization
Chapter 8: Downstream systems optimization
Chapter 9: Single-use manufacturing systems (SUMS)
Chapter 10: Commercial manufacturing overview
Chapter 11: Outsourcing considerations
Vol-2: Biosimilars and Interchangeable Biologics: Strategic Elements
Chapter 1: Introduction to biosimilar and interchangeable products
Chapter 2: Intellectual property issues for biosimilars
Chapter 3: European regulatory guidance
Chapter 4: EMA-approved biosimilars
Chapter 5: FDA regulatory guidance
Chapter 6: ROW regulatory guidance
Chapter 7: U.S. commercialization
Chapter 8: Global commercialization
Chapter 9: Quality and lifecycle management
لینک کوتاه : https://bookbaz.ir/?p=26543
نویسنده : Sarfaraz K. Niazi
ناشر : CRC Press; 1 edition
سال انتشار : 2016
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 1268
(ISBN) شابک : 1482298910
قیمت کتاب درآمازون : $332.66
حجم فایل : 17 MB