A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesised via a chemical process. Biologics often require special handling (such as refrigeration) and are usually administered to patients via injection or infused directly into the bloodstream. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the biologics provisions in the new healthcare reform bill signed into law under President Obama, entitled the Patient Protection and Affordable Care Act (PPACA).
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Zustand: New. Editor(s): Gutierrez, Daniel J. Num Pages: 148 pages, tables. BIC Classification: TCB. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly. Dimension: 252 x 173 x 15. Weight in Grams: 450. . 2011. Hardcover. . . . . Books ship from the US and Ireland. Artikel-Nr. V9781611220766
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