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The untold story behind the Star Trek Television series that almost was the Lost Series.
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.
In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biosta
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
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.
Written by the American Society of PeriAnesthesia Nurses (ASPAN), this all-in-one reference includes the vital information needed to succeed on the CAPA and CPAN certification exams and excel in practice. Includes new chapters on bariatric care and and newest guidelines.
Zenith is the only superhuman popstar. He's saved the world, had a number one record - but his only interests are women, drugs, alchohol and fame. But Peter St. John and the unexpected reappearance of Ruby forces the superbrat to take off and tackle a nuclear threat to London - from his own creator
The terms phase transitions and phase transformations are often used in an interchangeable manner in the metallurgical literature. In Phase Transformations, transformations driven by pressure changes, radiation and deformation and those occurring in nanoscale multilayers are brought to the fore. Order-disorder transformations, many of which constitute very good examples of continuous transformations, are dealt with in a comprehensive manner. Almost all types of phase transformations and reactions that are commonly encountered in inorganic materials are covered and the underlying thermodynamic, kinetic and crystallographic aspects elucidated. Shows readers the advancements in the field - due to enhanced computing power and superior experimental capability Drawing upon the background and the research experience of the authors, bringing together a wealth of experience Written essentially from a physical metallurgists view point
Partitioning in Aqueous Two-Phase Systems: Theory, Methods, Uses, and Applications to Biotechnology is a collection of papers that discusses the applications of aqueous two-phase systems to problems of separation and extraction of macromolecules, organelles, and cells. Papers focus on the theoretical basis and the practical details of the procedures used. Some of the papers describe in one or a few steps how two components can be separated by the investigator manipulating their partitions so that one component is in one phase and the other component is in the other phase or at the interface. Investigators can also avail of developed batch extractions for plant organelles, cell membranes, nucleic acids, and proteins. The book cites as an example the partitioning of right-side-out and inside-out vesicles (obtained from fragments of thylakoid membranes) to the top and bottom phases, respectively, of a Dx-PEG system. Other papers describe the use of the countercurrent distribution when single extraction steps are not sufficient to produce a separation in materials that do not differ greatly in their partitioning behavior. The collection can prove valuable for bio-chemists, cellular biologists, micro-biologists, and developmental biologists.