{"product_id":"statistical-thinking-for-non-statisticians-in-drug-regulation-by-richard-kay-gor011520090","title":"Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay ISBN 9781118470947","description":"\u003cp\u003e\u003cb\u003eStatistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eSTATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStatistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. \u003c\/p\u003e \u003cp\u003e\u003ci\u003eStatistical Thinking for Non-Statisticians in Drug Regulation\u003c\/i\u003e provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. \u003c\/p\u003e \u003cp\u003eThe third edition of \u003ci\u003eStatistical Thinking for Non-Statisticians in Drug Regulation\u003c\/i\u003e includes: \u003c\/p\u003e \u003cul\u003e\n\u003cli\u003eA detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9\u003c\/li\u003e\n\u003cli\u003eMajor new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis\u003c\/li\u003e\n\u003cli\u003eUpdated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eStatistical Thinking for Non-Statisticians in Drug Regulation\u003c\/i\u003e is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development. \u003c\/p\u003e\u003ch3\u003eBook details\u003c\/h3\u003e\u003ctable style=\"border-collapse: collapse; width: 100%; \"\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eSKU\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eGOR011520090\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eISBN 13\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003e9781118470947\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eISBN 10\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003e111847094X\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eAuthor\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eRichard Kay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eCondition\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eVery Good\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eBinding Type\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003ePublisher\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eJohn Wiley \u0026amp; Sons Inc\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eYear published\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003e2014-11-17\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eNumber of pages\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003e368\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth style=\"text-align: left; padding: 6px 10px; border: 1px solid #ddd; \"\u003eCover note\u003c\/th\u003e\n\u003ctd style=\"padding: 6px 10px; border: 1px solid #ddd; \"\u003eBook picture is for illustrative purposes only, actual binding, cover or edition may vary. \u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\u003c\/table\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":67723196301557,"sku":"GOR011520090","price":39.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0795\/8632\/8821\/files\/B01CCPZSDE.jpg?v=1792159742","url":"https:\/\/arbiyas.com\/products\/statistical-thinking-for-non-statisticians-in-drug-regulation-by-richard-kay-gor011520090","provider":"Arbiyas","version":"1.0","type":"link"}