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Clinical Prediction Models : A Practical Approach to Development, Validation, and Updating
The second edition of this volume provides insight and practical illustrations on how modern statistical concepts and regression methods can be applied in medical prediction problems, including diagnostic and prognostic outcomes.Many advances have been made in statistical approaches towards outcome prediction, but a sensible strategy is needed for model development, validation, and updating, such that prediction models can better support medical practice. There is an increasing need for personalized evidence-based medicine that uses an individualized approach to medical decision-making. In this Big Data era, there is expanded access to large volumes of routinely collected data and an increased number of applications for prediction models, such as targeted early detection of disease and individualized approaches to diagnostic testing and treatment. Clinical Prediction Models presents a practical checklist that needs to be considered for development of avalid prediction model.Steps include preliminary considerations such as dealing with missing values; coding of predictors; selection of main effects and interactions for a multivariable model; estimation of model parameters with shrinkage methods and incorporation of external data; evaluation of performance and usefulness; internal validation; and presentation formatting.The text also addresses common issues that make prediction models suboptimal, such as small sample sizes, exaggerated claims, and poor generalizability.The text is primarily intended for clinical epidemiologists and biostatisticians.Including many case studies and publicly available R code and data sets, the book is also appropriate as a textbook for a graduate course on predictive modeling in diagnosis and prognosis. While practical in nature, the book also provides a philosophical perspective on data analysis in medicine that goes beyond predictive modeling.Updates to this new and expanded edition include:• A discussion of Big Data and its implications for the design of prediction models• Machine learning issues• More simulations with missing ‘y’ values• Extended discussion on between-cohort heterogeneity• Description of ShinyApp• Updated LASSO illustration• New case studies
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Specification of Drug Substances and Products : Development and Validation of Analytical Methods
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods.This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices.It provides a hands-on guide to understanding and applying these in practice.The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.
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Diagnostic Writing Assessment : The Development and Validation of a Rating Scale
The diagnostic assessment of writing is an important aspect of language testing which has often been neclected in the literature.However, it is an area which poses special challenges to practioners both in the classroom and in large-scale testing situations.This book presents a study which set out to develop and validate a rating scale specifically designed for the diagnostic assessment of writing in an academic English setting.The scale was developed by analysing a large number of writing performances produced by both native speakers of English and learners of English as an additional language.The rating scale was then validated using both quantitative and qualitative methods.The study showed that a detailed data-based rating scale is more valid and more useful for diagnostic purposes than the more commonly used impressionistic rating scale.
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Validation : The New Psychology of Influence
Unlock the secret to true and lasting change'A crash course in the most important skills for forging connection and fuelling change.' ADAM GRANT'Profound, important, compassionate, Validation took my breath away.' AMY EDMONDSONWe all spend a huge amount of time trying to get people to listen to us, and despite our best efforts, we often fail.But what if the secret to influencing others was in first accepting them?This is known as validation: the act of showing someone that you understand their experience and accept it as valid. As both a means and an end, validation skills are proven to impact five key areas of our life: enhancing our relationships, de-escalating conflict, increasing our ability to drive behaviour change, influencing growth in others, and developing a stronger connection to self.In this groundbreaking book, Stanford University psychologist Caroline Fleck explains why validation is a catalyst for transformation, and shares her step-by-step framework to put this powerful skillset into practice.
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Chasing Masculinity : Men, Validation, and Infidelity
This book analyzes men's experiences and perceptions regarding their participation in infidelity and offers a glimpse into the inner workings of their most intimate relationships, as well as the ways men negotiate marriages that fall short of their expectations. Using a sample collected from the online dating service Ashley Madison, this book finds that contrary to gendered social scripts, the men in this study described motivations for outside partnerships that were not rooted in the desire for sexual pleasure or variety.Rather, men described those relationships as an outlet to soothe their bruised egos, receive attention and validation from a romantic partner, and to fight their feelings of emasculation.These infidelities thus provide support and praise, and aid in the processing of complex emotions. This in-depth analysis provides a unique insight into men's experiences of sexuality and masculinity, and will be of keen interest to those seeking to understand male infidelity from a sociological perspective, across gender studies, psychology, counselling, and beyond.
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Handbook of Validation in Pharmaceutical Processes, Fourth Edition
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive.This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions.As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes.Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features:Provides an in-depth discussion of recent advances in sterilizationIdentifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutionsExplores distinctive and specific process steps, and identifies critical process control points to reach acceptable resultsNew chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3).It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements.Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject.A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
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Verification, Validation, and Uncertainty Quantification in Scientific Computing
Can you trust results from modeling and simulation?This text provides a framework for assessing the reliability of and uncertainty included in the results used by decision makers and policy makers in industry and government.The emphasis is on models described by PDEs and their numerical solution.Procedures and results from all aspects of verification and validation are integrated with modern methods in uncertainty quantification and stochastic simulation.Methods for combining numerical approximation errors, uncertainty in model input parameters, and model form uncertainty are presented in order to estimate the uncertain response of a system in the presence of stochastic inputs and lack of knowledge uncertainty.This new edition has been extensively updated, including a fresh look at model accuracy assessment and the responsibilities of management for modeling and simulation activities.Extra homework problems and worked examples have been added to each chapter, suitable for course use or self-study.
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