Gang Li – författare

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

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

This insightful and timely volume provides a succinct, expert-led introduction to the latest developments in advanced econometric methodologies in the context of tourism demand modelling and forecasting.

Written by a plethora of worldwide experts on this topic, this book offers a comprehensive approach to tourism econometrics. Accurate demand forecasts are crucial to decision-making in the tourism industry and this book provides real-life tourism applications and the corresponding R code alongside theoretical foundations, in order to enhance understanding and practice amongst its readers. The methodologies introduced include general to specific modelling, cointegration, vector autoregression, time-varying parameter modelling, spatiotemporal econometric models, mixed-frequency forecasting, hybrid forecasting models, forecasting combination techniques, density forecasting, judgemental forecasting, scenario forecasting under crisis, and web-based tourism forecasting.

Embellished with insightful figures and tables throughout, this book is an invaluable resource for those using advanced econometric methodologies in their studies and research, including both undergraduate and postgraduate students, researchers, and practitioners.

This insightful and timely volume provides a succinct, expert-led introduction to the latest developments in advanced econometric methodologies in the context of tourism demand modelling and forecasting.

Written by a plethora of worldwide experts on this topic, this book offers a comprehensive approach to tourism econometrics. Accurate demand forecasts are crucial to decision-making in the tourism industry and this book provides real-life tourism applications and the corresponding R code alongside theoretical foundations, in order to enhance understanding and practice amongst its readers. The methodologies introduced include general to specific modelling, cointegration, vector autoregression, time-varying parameter modelling, spatiotemporal econometric models, mixed-frequency forecasting, hybrid forecasting models, forecasting combination techniques, density forecasting, judgemental forecasting, scenario forecasting under crisis, and web-based tourism forecasting.

Embellished with insightful figures and tables throughout, this book is an invaluable resource for those using advanced econometric methodologies in their studies and research, including both undergraduate and postgraduate students, researchers, and practitioners.

A comprehensive book focusing on the Force Analogy Method, a novel method for nonlinear dynamic analysis and simulation

This book focusses on the Force Analogy Method, a novel method for nonlinear dynamic analysis and simulation. A review of the current nonlinear analysis method for earthquake engineering will be summarized and explained. Additionally, how the force analogy method can be used in nonlinear static analysis will be discussed through several nonlinear static examples. The emphasis of this book is to extend and develop the force analogy method to performing dynamic analysis on structures under earthquake excitations, where the force analogy method is incorporated in the flexural element, axial element, shearing element and so on will be exhibited. Moreover, the geometric nonlinearity into nonlinear dynamic analysis algorithm based on the force analogy method is included. The application of the force analogy method in seismic design for buildings and structural control area is discussed and combined with practical engineering.

A comprehensive book focusing on the Force Analogy Method, a novel method for nonlinear dynamic analysis and simulation

This book focusses on the Force Analogy Method, a novel method for nonlinear dynamic analysis and simulation. A review of the current nonlinear analysis method for earthquake engineering will be summarized and explained. Additionally, how the force analogy method can be used in nonlinear static analysis will be discussed through several nonlinear static examples. The emphasis of this book is to extend and develop the force analogy method to performing dynamic analysis on structures under earthquake excitations, where the force analogy method is incorporated in the flexural element, axial element, shearing element and so on will be exhibited. Moreover, the geometric nonlinearity into nonlinear dynamic analysis algorithm based on the force analogy method is included. The application of the force analogy method in seismic design for buildings and structural control area is discussed and combined with practical engineering.

Longitudinal studies often incur several problems that challenge standard statistical methods for data analysis. These problems include non-ignorable missing data in longitudinal measurements of one or more response variables, informative observation times of longitudinal data, and survival analysis with intermittently measured time-dependent covariates that are subject to measurement error and/or substantial biological variation. Joint modeling of longitudinal and time-to-event data has emerged as a novel approach to handle these issues.

Joint Modeling of Longitudinal and Time-to-Event Data provides a systematic introduction and review of state-of-the-art statistical methodology in this active research field. The methods are illustrated by real data examples from a wide range of clinical research topics. A collection of data sets and software for practical implementation of the joint modeling methodologies are available through the book website.

This book serves as a reference book for scientific investigators who need to analyze longitudinal and/or survival data, as well as researchers developing methodology in this field. It may also be used as a textbook for a graduate level course in biostatistics or statistics.

Longitudinal studies often incur several problems that challenge standard statistical methods for data analysis. These problems include non-ignorable missing data in longitudinal measurements of one or more response variables, informative observation times of longitudinal data, and survival analysis with intermittently measured time-dependent covariates that are subject to measurement error and/or substantial biological variation. Joint modeling of longitudinal and time-to-event data has emerged as a novel approach to handle these issues.

Joint Modeling of Longitudinal and Time-to-Event Data provides a systematic introduction and review of state-of-the-art statistical methodology in this active research field. The methods are illustrated by real data examples from a wide range of clinical research topics. A collection of data sets and software for practical implementation of the joint modeling methodologies are available through the book website.

This book serves as a reference book for scientific investigators who need to analyze longitudinal and/or survival data, as well as researchers developing methodology in this field. It may also be used as a textbook for a graduate level course in biostatistics or statistics.

Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.