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A good understanding of medical statistics is essential to evaluate medical research and to choose appropriate ways of implementing findings in clinical practice. The Oxford Handbook of Medical Statistics has been written to provide doctors and medi…
A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the compone…
Researchers measure the effectiveness of new interventions using randomized controlled trials (RCTs). They are increasingly using qualitative research with these RCTs to explain the results of RCTs or facilitate the viability and efficiency of RCTs.…
Recent decades have brought advances in statistical theory for missing data, which, combined with advances in computing ability, have allowed implementation of a wide array of analyses. In fact, so many methods are available that it can be difficult…
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectiv…
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…
Explaining the assessment of potential drug compounds, this is an ideal introductory reference for those new to drug discovery. It includes sections on pharmacokinetics and drug metabolism, integration of pharmaceutical development, and predictive s…
Published in 1983: Volume 2 deals with critical analyses of various test methodologies of polymeric implants, including their acute and chronic toxicological evaluation.
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges…
1. Gives an overview of the development of drugs from peptides and proteins present in venom.2. Six drugs derived from venoms have already been approved, and there are many more in development.3. Medicinal chemists, pharmacologists, poisons experts,…
Explores the social inequality of clinical drug testing and its effects on scientific results Imagine that you volunteer for the clinical trial of an experimental drug. The only direct benefit of participating is that you will receive up to $5,175.…
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be…
This issue of Heart Failure Clinics is dedicated to an in-depth analysis of the conduct of clinical investigation in patients with acute decompensated heart failure (ADHF). It tackles the difficult questions involved in patient population, trial con…
The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design,…
Praise for the Second Edition:"... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressiv…
Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impress…
Review of the First Edition"The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and…
Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery. With extensively u…
Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems. Providing a comprehensive review of…
The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no b…
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial…
Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint.T…
First published in 1987: This book is intended as a guide for a very large group of practitioners in the medical, pharmaceutical, and biological fields. It will enable them to prescribe and use antibiotics in an improved way.
'Bad Science' hilariously exposed the tricks that quacks and journalists use to distort science, becoming a 400,000 copy bestseller. Now Ben Goldacre puts the $600bn global pharmaceutical industry under the microscope. What he reveals is a fascinati…
Genomics is majorly impacting therapeutics development in medicine. This book contains up-to-date information on the use of genomics in the design and analysis of therapeutic clinical trials with a focus on novel approaches that provide a reliable b…
Chronopharmaceutics covers the fundamentals of the various aspects of chronopharmaceutics in the fields of chronobiology, chronogenetics, chronophysiology, chronopathology, chronopharmacology, chronotherapeutics, chronotoxicology and chronobiotics,…
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows durin…
This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) in oncology. It provides not only methodological aspects of the dose-finding methods, but al…
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where the…
In 2010, the 5th edition of the textbook, "Statistics Applied to Clinical Studies", was published by Springer and since then has been widely distributed. The primary object of clinical trials of new drugs is to demonstrate efficacy rather than safet…
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 ph…
Clinical trials receive a lot of media attention; we hear or read about them almost daily in reports heralding new and promising treatments or reports raising questions about the safety or efficacy of an established treatment. The randomized trial i…
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evalua…
This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed…
This issue of the Psychiatric Clinics of North America will review Clinical issues and Affirmative Treatments with Transgendered Clients. Edited by Lynne Carroll and lore m. dickey, subjects discussed in the text include, but are not limited to, Ass…
Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and…
This set includes Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs & Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods. Volu…
Clinical simulations are practical learning experiences designed to give students exposure to a comprehensive range of clinical scenarios that may be encountered in the workplace.This book is a comprehensive reference guide to clinical simulations i…
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "noninformativeness" of the censoring mechanisms relative to the event. D…
Group Work With Populations at Risk, Third Edition is a fundamental resource for practitioners in health and mental health settings and a comprehensive guidebook of group work skills. Geared toward students and professionals gaining a beginning unde…
Review of the First Edition:The authors strive to reduce theory to a minimum, which makes it a self-learning text that is comprehensible for biologists, physicians, etc. who lack an advanced mathematics background. Unlike in many other textbooks, R…
The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plan…
This book provides guidance to the statisticians in industry on the non-technical "soft" skills that one needs to have in order to be successful as a statistician from the first day on the job until the last day. Focus is on oral and written communi…
Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodol…
Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on…
Design Principles and Analysis Techniques for HRQoL Clinical Trials SAS, R, and SPSS examples realistically show how to implement methodsFocusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edit…
This resource provides an integrated and comprehensive overview ofmodern approaches to drug lead discovery. Each chapter in this bookreviews the theoretical background and application of a keytechnology in drug discovery, complemented by relevant ca…
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow stati…