{"product_id":"biosimilars-and-interchangeable-biologics-sarfaraz-k-niazi-9781032652344","title":"Biosimilars and Interchangeable Biologics: Tactical Elements","description":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWhat's the Deal with Biosimilars?\u003c\/em\u003e\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eBiosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003ePart of a two-volume set that covers varying aspects of biosimilars, \u003cb\u003eBiosimilars and Interchangeable Biologics: Tactical Elements \u003c\/b\u003eexplores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eOf specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Sarfaraz K. Niazi\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1032652349\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781032652344\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/02\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 624\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 3.05lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 11.00h x 8.25w x 1.26d","brand":"Sarfaraz K. Niazi","offers":[{"title":"Paperback","offer_id":48443954233599,"sku":"9781032652344","price":70.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_3ffa1eb0-39f6-42bf-a41b-328b64de1de6.jpg?v=1777209004","url":"https:\/\/www.whiterainbookhouse.com\/products\/biosimilars-and-interchangeable-biologics-sarfaraz-k-niazi-9781032652344","provider":"WR Book House","version":"1.0","type":"link"}