{"product_id":"advanced-statistics-in-regulatory-critical-wei-zhang-9780367561789","title":"Advanced Statistics in Regulatory Critical Clinical Initiatives","description":"\u003cp\u003e\u003cb\u003e\u003ci\u003eAdvanced Statistics in Regulatory Critical Clinical Initiatives \u003c\/i\u003e\u003c\/b\u003eis focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. \u003cb\u003e\u003ci\u003eAdvanced Statistics in Regulatory Critical Clinical Initiatives \u003c\/i\u003e\u003c\/b\u003eprovides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields.\u003c\/p\u003e \u003cp\u003eKey Features: \u003c\/p\u003e \u003cul\u003e \u003cli\u003eProvides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review\/approval of drug development.\u003c\/li\u003e \u003cli\u003eMakes recommendations to evaluate submissions accurately and reliably.\u003c\/li\u003e \u003cli\u003eProposes innovative study designs and statistical methods for oncology and\/or rare disease drug development.\u003c\/li\u003e \u003cli\u003eProvides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.\u003c\/li\u003e\n\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Wei Zhang\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0367561786\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780367561789\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/26\/2022\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 307\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.69lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 0.75d\u003c\/ul\u003e","brand":"Wei Zhang","offers":[{"title":"Hardcover","offer_id":44149536751871,"sku":"9780367561789","price":190.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_e7710db6-02a3-4c69-b73a-09309f18ffcb.jpg?v=1688457200","url":"https:\/\/www.whiterainbookhouse.com\/products\/advanced-statistics-in-regulatory-critical-wei-zhang-9780367561789","provider":"WR Book House","version":"1.0","type":"link"}