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1. |
Record Nr. |
UNICAMPANIAVAN0178808 |
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Autore |
Sun, Chang Q. |
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Titolo |
The Attribute of Water : Single Notion, Multiple Myths / Chang Q. Sun, Yi Sun |
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Pubbl/distr/stampa |
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Singapore, : Springer, 2016 |
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Titolo uniforme |
The Attribute of Water : Single Notion, Multiple Myths |
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Descrizione fisica |
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xxxi, 494 p. : ill. ; 24 cm |
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Altri autori (Persone) |
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Soggetti |
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00A79 (77-XX) - Physics [MSC 2020] |
92C40 - Biochemistry, molecular biology [MSC 2020] |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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2. |
Record Nr. |
UNINA9910592986603321 |
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Autore |
Lian Yuming <1964-> |
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Titolo |
Sovereignty Blockchain 2.0 : New Forces Changing the World of Future / / by Lian Yuming |
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Pubbl/distr/stampa |
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Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2022 |
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ISBN |
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9789811938627 |
9789811938610 |
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Edizione |
[1st ed. 2022.] |
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Descrizione fisica |
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1 online resource (240 pages) |
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Disciplina |
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Soggetti |
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Technology - Moral and ethical aspects |
Blockchains (Databases) |
Social evolution |
Ethics of Technology |
Blockchain |
Social Evolution |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Nota di bibliografia |
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Includes bibliographical references (pages 201-216) and index. |
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Nota di contenuto |
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Super Public Goods -- Digital Currency -- Digital Identity -- Digital Order -- The Reconstruction of Civilization. |
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Sommario/riassunto |
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This book is a continuation and deepening of Sovereign Blockchain 1.0. It mainly includes three views: 1) Blockchain is a super public product based on digital civilization. 2) The Internet is an advanced level of industrial civilization, the core of which is connection; blockchain is an important symbol of digital civilization, the essence of which is reconstruction. 3) Digital currency will trigger a comprehensive change in the economic field, and digital identity will reconstruct the governance model in the social field, thereby changing the order of civilization. This book is not only a popular science book based on blockchain thinking, theory and application research, but also a scholarly work on the technical and philosophical issues of governance and the future. By reading Sovereign Blockchain 2.0, policymakers can quickly understand the basic knowledge and frontier dynamics of science and technology; science and technology workers can grasp the general trend, seize opportunities, face problems and difficulties, aim at the world's science and technology frontier and lead the direction of science and technology development; experts and scholars in law and legal fields can see new ideas, concepts and models of data governance; social science researchers can discover data sociology and data philosophy issues. . |
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3. |
Record Nr. |
UNINA9910299977903321 |
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Titolo |
Practical Considerations for Adaptive Trial Design and Implementation / / edited by Weili He, José Pinheiro, Olga M. Kuznetsova |
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Pubbl/distr/stampa |
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New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 |
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ISBN |
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Edizione |
[1st ed. 2014.] |
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Descrizione fisica |
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1 online resource (420 p.) |
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Collana |
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Statistics for Biology and Health, , 2197-5671 |
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Disciplina |
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Soggetti |
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Biometry |
Pharmacovigilance |
Statistics |
Biostatistics |
Drug Safety and Pharmacovigilance |
Statistical Theory and Methods |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index at the end of each chapters. |
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Nota di contenuto |
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Preface -- The Need for and the Future of Adaptive Designs in Clinical Development -- Regulatory Guidance Documents on Adaptive Designs: an Industry Perspective -- A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences -- Considerations and optimization of adaptive trial design in clinical development programs -- Optimal Cost-effective Go-No Go Decisions in Clinical Development -- Timing and frequency of interim analyses in confirmatory trials -- Approaches for optimal dose selection for adaptive design trials -- A Review of Available Software and Capabilities for Adaptive Designs -- Randomization Challenges in Adaptive Design Studies -- Response-adaptive randomization for clinical trials -- Implementing Adaptive Designs: Operational Considerations, Putting it all together -- Implementation Issues in Adaptive Design Trials -- Implementing Adaptive Designs; Using Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust -- Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of |
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DMCs -- Approaches for Clinical Supply Modelling and Simulation -- Approaches for Patient Recruitment Modeling and Simulation -- A case study for adaptive trial design consideration and implementation -- Design Considerations for a Phase Ib Randomized, Placebo-Controlled, 4-Period Cross-over Adaptive Dose-Finding Clinical Trial -- Continual Reassessment Method for a First-In-Human Trial: From Design to Trial Implementation -- Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and its Implementation: ADVENT Trial. |
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Sommario/riassunto |
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This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specificadaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation. |
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