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Cargando... Jarastavens vandring. Bok 6, Dödens vingslagpor Saga Borg
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This book explores the regulatory, scientific, intellectual property protection, and business perspectives related to generic biotech products (more accurately, the term for this type of product should be biosimilars or follow-on protein products). The book describes the current U.S. legal framework regulating biotech products and identifies the regulatory obstacles to establishing regulatory mechanisms for the approval of the patent-expired biological products. Most importantly, the book focuses on the identification of the scientific challenges when developing regulatory requirements and scientific standards for review and approval of biosimilar products, and the scientific knowledge and principles required to make a similar / comparable product. In addition, business considerations and issues related to intellectual property protection are also discussed. No se han encontrado descripciones de biblioteca. |
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