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ISBN 10: 0367565609 ISBN 13: 9780367565602
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hardcover. Condition: USED_FINE. Open Books is a nonprofit social venture that provides literacy experiences for thousands of readers each year through inspiring programs and creative capitalization of books.
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
Seller: Open Books, Chicago, IL, U.S.A.
hardcover. Condition: NEW. Open Books is a nonprofit social venture that provides literacy experiences for thousands of readers each year through inspiring programs and creative capitalization of books.
Published by Chapman and Hall/CRC, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
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Published by Chapman and Hall/CRC, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
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ISBN 10: 0367625792 ISBN 13: 9780367625795
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Paperback. Condition: NEW. Paperback. Global 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.After the publication of the editors first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) 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. Simultaneous 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. This 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.This book is comprehensive across the MRCT topic spectrum, including Issues regarding ICH E17 Implementation MRCT Design and Analysis Methodologies Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry Many examples of real-life applications based on actual MRCTs. This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.
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ISBN 10: 0367625792 ISBN 13: 9780367625795
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ISBN 10: 0367625792 ISBN 13: 9780367625795
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Published by CRC Press, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
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Condition: NEW. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored ov.
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC 2021-12-30, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
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Published by CRC Press Jan 2024, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
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Taschenbuch. Condition: NEW. Neuware - This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.
Published by Taylor & Francis Ltd, 2024
ISBN 10: 0367625792 ISBN 13: 9780367625795
Seller: AussieBookSeller, Truganina, VIC, Australia
Paperback. Condition: NEW. Paperback. Global 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.After the publication of the editors first volume on this topic, there have been new developments on MRCTs. The International Council for Harmonisation (ICH) 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. Simultaneous 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. This 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.This book is comprehensive across the MRCT topic spectrum, including Issues regarding ICH E17 Implementation MRCT Design and Analysis Methodologies Perspectives from authorities in regulatory agencies, as well as statisticians practicing in the medical product industry Many examples of real-life applications based on actual MRCTs. This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability.
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Taylor & Francis Ltd, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Taylor and Francis Ltd (Sales), 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
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Published by CRC Press, 2021
ISBN 10: 0367565609 ISBN 13: 9780367565602
Seller: moluna, Greven, Germany
Gebunden. Condition: NEW. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored ov.