Titlebook: Biosimilars; Regulatory, Clinical Hiten J. Gutka,Harry Yang,Shefali Kakar Book 2018 American Association of Pharmaceutical Scientists 2018

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https://doi.org/10.1007/978-3-540-79084-6milar is expected to produce clinical outcomes that are not meaningfully different from those expected with the reference biologic drug. This chapter is intended to present the Canadian clinical information requirements for biosimilars, and how they relate to the Canadian regulatory framework, while

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https://doi.org/10.1007/978-3-031-00307-3biologic. The concepts become even more critical with the development of biosimilar molecules, where decisions that are made at very early stages with respect to cell lines, fermentation parameters, and purification strategy will impact the chemical and physical properties of the product. A thorough

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https://doi.org/10.1007/978-981-10-8100-2xpectations for approval of protein-based biosimilars in key regions of the world with known requirements for marketing authorization. The authors then demonstrate how analytical characterization methods may be managed within a broad and general lifecycle characterization framework. It is the author

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Lecture Notes in Computer Scienceormat and magnetic beads-based Luminex format. The first few sections of this chapter will focus on the applications and findings from the ELISA-based PCA and the last two sections will discuss the Luminex system in elucidating detains of mAbs HOS under different stress conditions. Results will be d

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Biosimilars 101: An Introduction to Biosimilarsic profiles, and comparative clinical trial data to eliminate any residual uncertainty. Beyond development and regulatory complexities, much of the fascination with biosimilars stems from ongoing efforts to establish unique commercialization blueprints, educate stakeholders, and collect and present

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The Changing US Reimbursement Landscape and Biosimilars weigh in with their own coverage decisions, but typically follow the coding of biosimilars as set forth by CMS. This chapter will assess the existing reimbursement landscape for biosimilars and will address key considerations and implications around current decisions that will impact biosimilars’ m