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Simultaneous Global New Drug Development

2021-12-15 Mathematics
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Release : 2021-12-15
Genre : Mathematics
Kind : eBook
Book Rating : 021/5 ( reviews)

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Book Synopsis Simultaneous Global New Drug Development by : Gang Li

Download or read book Simultaneous Global New Drug Development written by Gang Li. This book was released on 2021-12-15. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Multiregional Clinical Trials for Simultaneous Global New Drug Development

2016-04-21 Mathematics
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Release : 2016-04-21
Genre : Mathematics
Kind : eBook
Book Rating : 485/5 ( reviews)

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Book Synopsis Multiregional Clinical Trials for Simultaneous Global New Drug Development by : Joshua Chen

Download or read book Multiregional Clinical Trials for Simultaneous Global New Drug Development written by Joshua Chen. This book was released on 2016-04-21. Available in PDF, EPUB and Kindle. Book excerpt: In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Phase II Clinical Development of New Drugs

2017-04-08 Medical
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Release : 2017-04-08
Genre : Medical
Kind : eBook
Book Rating : 946/5 ( reviews)

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Book Synopsis Phase II Clinical Development of New Drugs by : Naitee Ting

Download or read book Phase II Clinical Development of New Drugs written by Naitee Ting. This book was released on 2017-04-08. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

Global Clinical Trials Playbook

2012-04-20 Medical
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Release : 2012-04-20
Genre : Medical
Kind : eBook
Book Rating : 874/5 ( reviews)

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Book Synopsis Global Clinical Trials Playbook by : Menghis Bairu

Download or read book Global Clinical Trials Playbook written by Menghis Bairu. This book was released on 2012-04-20. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Simultaneous Global New Drug Development

2024-01-29 Mathematics
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Release : 2024-01-29
Genre : Mathematics
Kind : eBook
Book Rating : 795/5 ( reviews)

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Book Synopsis Simultaneous Global New Drug Development by : Gang Li

Download or read book Simultaneous Global New Drug Development written by Gang Li. This book was released on 2024-01-29. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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