The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applicatio...

As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development. Clinical Trial Modernization: Technological, Operational, and Regulatory Advances provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field.Th...

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development.Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algo...

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra

Peace on Earth: The Role of Religion in Peace and Conflict Studies provides a critical analysis of faith and religious institutions in peacebuilding practice and pedagogy. The work captures the synergistic relationships among faith traditions and how multiple approaches to conflict transformation and peacebuilding result in a creative process that has the potential to achieve a more detailed view of peace on earth, containing breadth as well as depth.Library and bookstore shelves ar...

A must-have collection for comics fans and creators everywhere, packed with interviews and original comics by today’s foremost graphic novelists.Respected anthologist Leonard S. Marcus turns his literary microscope to the world of comics, which has lately morphed and matured at a furious pace. Powerful influences from manga to the movies to underground comix have influenced the thirteen artists and writers interviewed in these pages to create their own word-and-pic...

Advances in RNA-sequencing (RNA-seq) technologies have provided an unprecedented opportunity to explore the gene expression landscape across individuals, tissues, and environments by efficiently profiling the RNA sequences present in the samples. When a reference genome sequence or a transcriptome of the sample is available, mapping-based RNA-seq analysis protocols align the RNA-seq reads to the reference sequences, identify novel transcripts, and quantify the abundance of expressed transc...

Decades of theory, research, and practice have singled out sense of belonging (in its many derivative forms) as a pivotal component of healthy development: psychologically, socially, culturally, academically. The human need for belonging, and therefore its essential nature, have been well established across multiple arenas. Despite growth in this field, answers to the barriers to belonging among marginalized groups and contexts remain especially elusive. For decades, this work was anchored...

This book describes the distribution of bamboo forest and bamboo species for construction, the types and characteristics of both engineered and natural full-culm bamboo materials for construction, the development history and research status of different forms of bamboo architecture. We go on to describe standards, relevant international organizations, research institutions and production and processing enterprises and typical cases. Starting from six aspects, this book systematically descr...

In the late 1970s Islam regained its force by generating novel forms of piety and forging new paths in politics throughout the world, including China. The Islamic revival in China, which came to fruition in the 2000s and the 2010s, prompted increases in government suppression but also intriguing resonances with the broader Muslim world—from influential theoretical and political contestations over Muslim women’s status, the popularization of mass media and the appearance of new patterns of ...

An Alphabet of Embers is an anthology of unclassifiables – lyrical, surreal, magical, experimental pieces that straddle the border between poetry and prose. It lives in a place between darkness and sound, between roads and breaths, its pages taut with starlight; between its covers, words talk to each other, and have an occasional cup of tea.Edited by Rose Lemberg, featuring work by:Alvaro Zinos-AmaroAmal El-MohtarArkady MartineCeleste Rita Baker...

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of ...