Biosimilars : regulatory, clinical, and biopharmaceutical development /: regulatory, clinical, and biopharmaceutical development. (2018)

• Record Type: Book
• Further Information: Note: Edited by Hiten J. Gutka, Harry Yang, Shefali Kakar.
• Editors: Gutka, Hiten J; Yang, Harry; Kakar, Shefali
• Contents: Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape -- Biosimilars 101 - An Introduction to Biosimilars -- Innovation, Patents and Biologics: The Road to Biosimilar Competition -- Factors influencing investment, business decisions and marketing of biosimilars -- The Changing US Reimbursement Landscape and Biosimilars -- Litigation-Related Issues Under The Biologics Price Competition and Innovation Act -- Section II: Target Product Profile, QbD, CMC, Biosimilar manufacture platform technologies -- Design and implementation of successful regulatory strategies in biosimilar development -- Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges -- EU Perspective on Biosimilars -- Section III: Pharmaceutical development of Biosimilars; analytical comparability; higher order structure -- QbD in biopharmaceutical manufacturing and biosimilar development -- Drug Product Development and Manufacturing considerations for biosimilars -- Section IV: Biosimilars- clinical and non-clinical development; immunogenicity; Extrapolation and Interchangeability -- Principles of Analytical Biosimilarity Assessment -- Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars -- Higher Order Structure methods for similarity assessment -- Protein Conformational Array for Biologics Higher Order Structure Similarity Analysis -- Protein particulates and biosimilar development: analytical tools and therapeutic implications -- Biological activity assays for antibody therapeutics -- Statistical Considerations for Demonstration of Analytical Similarity -- Section V: Biosimilars- Global development and clinical experience -- Comparative clinical studies for biosimilar development -- Immunogenicity assessment of biosimilars: A multidisciplinary perspective -- Interchangeability of biosimilar therapeutics -- Extrapolation of Biosimilars -- Totality of evidence and the role of clinical studies in establishing biosimilarity -- Section VI: Biosimilars- Global Development and Clinical Experience -- Pharmacovigilance of Biosimilars - Global experience and perspective -- Development and Commercialization of Biosimilars in India - Current Regulatory and Clinical Experience.-Immunogenicty and adverse reactions to biocopy erythropoietins: The quality issues.
• Publisher Details: Cham : Springer
• Publication Date: 2018
• Extent: 1 online resource, illustrations
• Subjects: 615.19; Pharmaceutical technology; Pharmacy; Pharmaceutical technology; Pharmacy; Electronic books
• Languages: English
• ISBNs: 9783319996806; 3319996800
• Related ISBNs: 3319996797; 9783319996790
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.