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Patient-Reported Outcomes
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the healt
The Psychology of Health
The first edition of The Psychology of Health has become the standard recommended text for many courses. This completely revised and updated second edition contains new material in all chapters and has several additional chapters on such topics as cancer, nutrition and exercise, social drugs, and the impact of social inequalities upon health. The Psychology of Health will continue to be invaluable for students of health psychology and related fields, including nursing, social work, community care and health studies. The Psychology of Health, second edition, is: * comprehensive: its four parts cover the scope and ambition of health psychology, acute and chronic illness, hospitalisation and th...
Quantitative Evaluation of Safety in Drug Development
State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve
Textbook of Female Urology and Urogynecology
Featuring contributions by an international team of the world’s experts in urology and gynecology, this fifth edition reinforces its status as the classic comprehensive resource on female urology and urogynecology and an essential clinical reference in the field, with new chapters throughout. Each volume is now available separately. *Offers a comprehensive guide to medical aspects *Covers important classic and newer topics *Presents a practical and manageable level of detail
Mixed Effects Models for the Population Approach
Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects Models Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whole population of individuals at the same time. Easy-to-Use Techniques and Tools for Real-World Data Modeling The book first shows how the framework allows model representation for different data types, including continuous, categorical, count, and time-to-event data. This leads to the use of generic methods, such as the stochastic approximation of ...
Inference Principles for Biostatisticians
Designed for students training to become biostatisticians as well as practicing biostatisticians, Inference Principles for Biostatisticians presents the theoretical and conceptual foundations of biostatistics. It covers the theoretical underpinnings essential to understanding subsequent core methodologies in the field. Drawing on his extensive experience teaching graduate-level biostatistics courses and working in the pharmaceutical industry, the author explains the main principles of statistical inference with many examples and exercises. Extended examples illustrate key concepts in depth using a specific biostatistical context. In addition, the author uses simulation to reinforce the repeated sampling interpretation of numerous statistical concepts. Reducing the computational complexities, he provides simple R functions for conducting simulation studies. This text gives graduate students with diverse backgrounds across the health, medical, social, and mathematical sciences a solid, unified foundation in the principles of statistical inference. This groundwork will lead students to develop a thorough understanding of biostatistical methodology.
Clinical and Statistical Considerations in Personalized Medicine
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease Treatment The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subseq...
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research
Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas...
Handbook of Clinical Sexuality for Mental Health Professionals
The Handbook of Clinical Sexuality for Mental Health Professionals, 3rd Edition, builds on the authors’ authoritative first person voice on sexual matters of the previous editions. The work reflects the field's growing sophistication about sexual disorders and their therapies. The scope has been expanded to keep pace with new literature and research in the field, and eight additional chapters have been added. New topics include the politics of diagnosis, persistent genital arousal, asexuality, post orgasm illness, scientific findings concerning origin of orientation, and partnering with the pharmaceutical industry. Easily accessible, the Handbook is divided into sections that touch on fundamental knowledge and skills; treatment; men’s major sexual concerns; women’s major sexual concerns; problems common to both genders; the diversity of sexual lives; and future and trending topics. Written in a personal, supervisory style, the book will help new therapists anticipate clinical contingencies and help experienced therapists refine their thinking and teaching.
Adaptive Design Theory and Implementation Using SAS and R, Second Edition
Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More ana...
