{"product_id":"simultaneous-global-new-drug-development-paperback-softback","title":"Simultaneous Global New Drug Development - Paperback \/ softback","description":"\u003cp\u003eGlobal simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from many geographical regions around the world, MRCTs can speed up the patient enrolment, thus resulting in quicker drug development and obtaining faster approval of the drug globally.\u003c\/p\u003e\u003cp\u003eAfter the publication of the editors’ first volume on this topic, there have been new developments on MRCTs. The \u003ci\u003eInternational Council for Harmonisation (ICH)\u003c\/i\u003e issued ICH E17, a guideline document on MRCTs, in November 2017, laying out principles on MRCTs. Beyond E17, new methodologies have been developed as well. \u003c\/p\u003e\u003cp\u003eSimultaneous Global New Drug Development: Multi-Regional Clinical Trials after ICH E17 collects chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. In addition, in contrast to the first book, new perspectives are brought to MRCT from regulatory agencies. \u003c\/p\u003e\u003cp\u003eThis book will be of particular interest to biostatisticians working in late stage clinical development of medical products. It will also be especially helpful for statisticians in regulatory agencies, and medical research institutes.\u003c\/p\u003e\u003cp\u003eThis book is comprehensive across the MRCT topic spectrum, including\u003c\/p\u003e\u003cul\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eIssues regarding ICH E17 Implementation\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eMRCT Design and Analysis Methodologies\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003ePerspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry\u003c\/li\u003e \u003cp\u003e \u003c\/p\u003e \u003cli\u003eMany examples of real-life applications based on actual MRCTs.\u003c\/li\u003e \u003c\/ul\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":45584662921454,"sku":"9780367625795","price":121.6,"currency_code":"AUD","in_stock":true}],"url":"https:\/\/bookland.com.au\/products\/simultaneous-global-new-drug-development-paperback-softback","provider":"Book Land AU","version":"1.0","type":"link"}