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Key Statistical Concepts in Clinical Trials for Pharma
This Brief 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.
New Drug Development
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is...
New Drug Development
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Temperament
Temperament is the first monograph in 40 years to present theories and basic findings in the field of temperament from a broad international and interdisciplinary perspective. The text, based on the author's four decades of personal study and data collection, thoroughly explores the physiological, biochemical, and genetic bases of temperament - incorporating age-specific methods of assessment developed through child- and adult-oriented approaches. The 147 illustrations comprise tables of the most popular temperament inventories for both children and adults, and unique data tables illustrating the psychometric features of temperament inventories based on self-rating and rating by others.
Introduction to Analysis of Variance: Design, Analyis & Interpretation
Besides introducing the concepts and types of one of the most powerful and prevalent statistical techniques in experimental behavioral science research, this text also shows students how to perform analysis of variance using a calculator to provide a better feel for evaluating data than relying on an ANOVA computer program. Appendices include standard statistical tables and answers to chapter exercises.
Phantom Pain
Phantom pain is an intriguing mystery that has captured the imagination of health care providers and the public alike. How is it possible to feel pain in a limb or some other body part that has been surgically removed? Phantom pain develops among people who have lost a limb or a breast or have had internal organs removed. It also occurs in people with totally transected spinal cords. Unfortunately, phantom pain is a medical night mare. Many of the people reporting phantom pain make dispropor tionately heavy use of the medical system because their severe pains are usually not treated successfully. The effect on quality of life can be devas tating. Phantom pain has been reported at least since...
Test Anxiety
Examination stress and test anxiety are pervasive problems in modern society. As the information age continues to evolve, test scores will become even more important than they are today in evaluating applicants for demanding jobs and candidates for admission into highly competitive educational programs. Because test anxiety gen- ally causes decrements in performance and undermines academic achievement, the development of effective therapeutic interventions for reducing its adverse effects will continue to be an important priority for counselors, psychologists, and educators. Alleviating test anxiety will also serve to counteract the diminished access to edu- tional and occupational opportuni...
A Concise Guide to Clinical Trials
Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific dis...
Schizophrenic Disorders:
No diagnosis of mental disorder is more important or more disputable than that of "schizophrenia." The 1982 case of John Hinckley, who shot President Reagan, brought both aspects of this diagnostic dilemma to the forefront of national attention. It became evident to the general public that the experts engaged to study him exhaustively could not agree on whether Hinckley was schizophrenic. General public outrage ensued, as schizophrenia, "the sacred symbol of psychiatry," in the words of Thomas Szasz (1976), emerged as a king of Alice in Wonderland travesty. Schizo phrenia seemed not to be a legitimate diagnostic entity but some sort of facade erected to protect the guilty. In 1973, David Rosenhan had already shown the readers of Science that schizo phrenia was a label that could be given to normal people presenting with a supposed auditory hallucination on even one occasion. In Rosenhan's studies, mental health professionals were outclassed by the regular psychiatric hospital patients, who cor rectly saw the false schizophrenics as imposters while the professional diagnosticians continued to fool themselves.
