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Noninferiority Testing in Clinical Trials

, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect;

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Noninferiority Testing in Clinical Trials

Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active;

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Fundamental Concepts for New Clinical Trialists

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and;

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Fundamental Concepts for New Clinical Trialists

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and;

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Statistics in Drug Research

performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines;

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Statistics in Drug Research

performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines;

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Strategy and Statistics in Clinical Trials

clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size;

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Multiple Testing Problems in Pharmaceutical Statistics

controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical;

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Oncology Clinical Trials

: Outlines how to design clinical trials with and without biomarker testing-including genomics-based basket trials, and adaptive trials for all;

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Pediatric Non-Clinical Drug Testing

practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation;

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Bioequivalence and Statistics in Clinical Pharmacology

tools useful for other topics of clinical pharmacology - namely general safety testing, testing for proarrythmic potential, population;

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Efficacy Analysis in Clinical Trials an Update

Machine learning and big data is hot. It is, however, virtually unused in clinical trials. This is so, because randomization is applied to;

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Design and Analysis of Clinical Trials with Time-To-Event Endpoints

, number of events, and independence or noninformativeness of the censoring mechanisms relative to the event. Design and Analysis of Clinical;

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Clinical Trials in Surgical Oncology, An Issue of Surgical Oncology Clinics of North America

This issue of Surgical Oncology Clinics of North America, guest edited by Dr. Elin R. Sigurdson, is devoted to Clinical Trials in Surgical;

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Bioequivalence and Statistics in Clinical Pharmacology

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day;

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Bioequivalence and Statistics in Clinical Pharmacology

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day;

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Clinical Trial Design

A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been;

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Statistical Design, Monitoring, and Analysis of Clinical Trials: Principles and Methods

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical;

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Statistics Applied to Clinical Trials

of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and;

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Behavioral Clinical Trials for Chronic Diseases

This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the;

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The Professional Guinea Pig

The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety;

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The Professional Guinea Pig

The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety;

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Cancer Clinical Trials

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the;

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Cancer Clinical Trials

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the;

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Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3E

The leading guide to the principles and clinical applications of evidence-based medicine--updated with new examples and new chaptersA;

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Gene Transfer and the Ethics of First-in-Human Research

and policy dimensions of testing interventions in human beings for the first time. The book discusses the difficult ethical challenges that;

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Equivalence and Noninferiority Tests for Quality, Manufacturing and Test Engineers

noninferiority tests. Equivalence and Noninferiority Tests for Quality, Manufacturing and Test Engineers presents methods for using validation and;

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