{"product_id":"biosimilarity-sarfaraz-k-niazi-9781498750394","title":"Biosimilarity: The FDA Perspective","description":"\u003cp\u003eSummary: \u003c\/p\u003e\u003cp\u003eThe focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.\u003c\/p\u003e\u003cp\u003eFeatures: \u003c\/p\u003e\u003cp\u003eFirst comprehensive analysis based on new guidelines and approval packages of several biosimilars\u003c\/p\u003e\u003cp\u003ePresents the first approach to challenge FDA in reducing or eliminating any testing in patients.\u003c\/p\u003e\u003cp\u003eProvides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines\u003c\/p\u003e\u003cp\u003eProvides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies\u003c\/p\u003e\u003cp\u003eAllow creation of a fast-to-market pathway to develop biosimilars\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Sarfaraz K. Niazi\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1498750397\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781498750394\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 07\/25\/2018\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 398\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.40lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.30w x 1.10d\u003c\/p\u003e","brand":"Sarfaraz K. Niazi","offers":[{"title":"Hardcover","offer_id":44124190343423,"sku":"9781498750394","price":220.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_21b1aa05-142f-46a1-83d7-efb6e356264b.jpg?v=1687435277","url":"https:\/\/www.whiterainbookhouse.com\/products\/biosimilarity-sarfaraz-k-niazi-9781498750394","provider":"WR Book House","version":"1.0","type":"link"}