Biosimilars : Regulatory, Clinical, and Biopharmaceutical Development / Hiten J. Gutka, Harry Yang, Shefali Kakar
Publication year: 2018
ISBN: 978-3-319-99680-6
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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.
Subject: Pharmacy, Pharmaceutics, Pharmaceutical technology, Pharmaceutical chemistry, Therapeutics, Quality by design, Biologics, preclinical safety, Chemistry and manufacturing controls (CMC), Analytical Similarity, Biosimilars
