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Abstrak :
The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology.

Abstrak :
This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

Abstrak :
The aim of this book is to provide an overview of some of the technology platforms that have been realized or are currently under development to try to address unsolved and new issues in the field of vaccine development.

Abstrak :
In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis.

Abstrak :
All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.

Abstrak :
This book focuses on new small molecule approaches to combat viral infections. The chapters describe the discovery and development from bench through the clinic of relatively recently-approved antiviral drugs and compounds in advanced clinical development. Organized by a virus (such as HIV, HCV, RSV, influenza, HBV and CMV) and written by top academic and industrial authorities in the field, the book provides a unique opportunity to study, understand and apply discovery and development principles and learning without the need for an individual to research, analyze and synthesize all immense sourcing references. Topics showcase challenges and solutions of issues encountered, offeringtremendous experience accumulated over many years of research that will be particularly useful to basic and bench scientists as well as clinicians as they continue discovering and developing new drugs and therapies.

Abstrak :
This book discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.

Abstrak :
The first part of this title contained all statistical tests relevant to starting clinical investigations, and included tests for continuous and binary data, power, sample size, multiple testing, variability, confounding, interaction, and reliability. The current part 2 of this title reviews methods for handling missing data, manipulated data, multiple confounders, predictions beyond observation, uncertainty of diagnostic tests, and the problems of outliers. Also robust tests, non-linear modeling , goodness of fit testing, Bhatacharya models, item response modeling, superiority testing, variability testing, binary partitioning for CART (classification and regression tree) methods, meta-analysis, and simple tests for incident analysis and unexpected observations at the workplace and reviewed. Each test method is reported together with (1) a data example from practice, (2) all steps to be taken using a scientific pocket calculator, and (3) the main results and their interpretation. Although several of the described methods can also be carried out with the help of statistical software, the latter procedure will be considerably slower.