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Statistics in Drug Research by Shein-Chung Chow,Jun Shao Pdf
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.
Drug Utilization Research by Monique Elseviers,Björn Wettermark,Anna Birna Almarsdóttir,Morten Andersen,Ria Benko,Marion Bennie,Irene Eriksson,Brian Godman,Janet Krska,Elisabetta Poluzzi,Kstja Taxis,Vera Vlahovic-Palcevski,Robert Vander Stichele Pdf
Drug Utilization Research (DUR) is an eclectic scientific discipline, integrating descriptive and analytical methods for the quantification, understanding and evaluation of the processes of prescribing, dispensing and consumption of medicines and for the testing of interventions to enhance the quality of these processes. The discipline is closely related and linked mainly to the broader field of pharmacoepidemiology, but also to health outcomes research, pharmacovigilance and health economics. Drug Utilization Research is a unique, practical guide to the assessment and evaluation of prescribing practices and to interventions to improve the use of medicines in populations. Edited by an international expert team from the International Society for Pharmacoepidemiology (ISPE), DUR is the only title to cover both the methodology and applications of drug utilization research and covers areas such as health policy, specific populations, therapeutics and adherence.
Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 118 pages File Size : 45,5 Mb Release : 2014-02-06 Category : Medical ISBN : 9780309292498
Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Kent B. Joscelyn,University of Michigan. Highway Safety Research Institute
Author : Kent B. Joscelyn,University of Michigan. Highway Safety Research Institute Publisher : Unknown Page : 88 pages File Size : 46,9 Mb Release : 1980 Category : Drinking and traffic accidents ISBN : NWU:35556029232873
Drug Research Methodology: The detection and quantification of drugs of interest in body fluids from drivers by Kent B. Joscelyn,University of Michigan. Highway Safety Research Institute Pdf
Principles of Research Design and Drug Literature Evaluation by Rajender R. Aparasu,John P. Bentley Pdf
Principles of Research Design and Drug Literature Evaluation is a unique resource that provides a balanced approach covering critical elements of clinical research, biostatistical principles, and scientific literature evaluation techniques for evidence-based medicine. This accessible text provides comprehensive course content that meets and exceeds the curriculum standards set by the Accreditation Council for Pharmacy Education (ACPE). Written by expert authors specializing in pharmacy practice and research, this valuable text will provide pharmacy students and practitioners with a thorough understanding of the principles and practices of drug literature evaluation with a strong grounding in research and biostatistical principles. Principles of Research Design and Drug Literature Evaluation is an ideal foundation for professional pharmacy students and a key resource for pharmacy residents, research fellows, practitioners, and clinical researchers. FEATURES * Chapter Pedagogy: Learning Objectives, Review Questions, References, and Online Resources * Instructor Resources: PowerPoint Presentations, Test Bank, and an Answer Key * Student Resources: a Navigate Companion Website, including Crossword Puzzles, Interactive Flash Cards, Interactive Glossary, Matching Questions, and Web Links From the Foreword: "This book was designed to provide and encourage practitioner’s development and use of critical drug information evaluation skills through a deeper understanding of the foundational principles of study design and statistical methods. Because guidance on how a study’s limited findings should not be used is rare, practitioners must understand and evaluate for themselves the veracity and implications of the inherently limited primary literature findings they use as sources of drug information to make evidence-based decisions together with their patients. The editors organized the book into three supporting sections to meet their pedagogical goals and address practitioners’ needs in translating research into practice. Thanks to the editors, authors, and content of this book, you can now be more prepared than ever before for translating research into practice." L. Douglas Ried, PhD, FAPhA Editor-in-Chief Emeritus, Journal of the American Pharmacists Association Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Texas at Tyler, Tyler, Texas
Traditional Herbal Medicine Research Methods by Willow J.H. Liu Pdf
This book introduces the methodology for collection and identification of herbal materials, extraction and isolation of compounds from herbs, in vitro bioassay, in vivo animal test, toxicology, and clinical trials of herbal research. To fully understand and make the best use of herbal medicines requires the close combination of chemistry, biochemistry, biology, pharmacology, and clinical science. Although there are many books about traditional medicines research, they mostly focus on either chemical or pharmacological study results of certain plants. This book, however, covers the systematic study and analysis of herbal medicines in general – including chemical isolation and identification, bioassay and mechanism study, pharmacological experiment, and quality control of the raw plant material and end products.
Drug Discovery and Evaluation: Methods in Clinical Pharmacology by H.Gerhard Vogel,Jochen Maas,Alexander Gebauer Pdf
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
In Vitro Methods in Pharmaceutical Research by Jose V. Castell,Maria Jose Gmez-Lechn Pdf
In Vitro Methods in Pharmaceutical Research provides a comprehensive guide to laboratory techniques for evaluating in vitro organ toxicity using cellular models. Step-by-step practical tips on how to perform and interpret assays for drug metabolism and toxicity assessment are provided, along with a comparison of different techniques available. It is a welcome addition to the literature at a time when interest is growing in cellular in vitro models for toxicology and pharmacology studies. Meets the continuing demand for information in this field Compares In Vitro techniques with other methods Describes cell-culture methods used to investigate toxicity in cells derived from different organs Includes contributions by leading experts in the field
Author : Peter G. Miller,John Strang,Peter M. Miller Publisher : John Wiley & Sons Page : 400 pages File Size : 50,5 Mb Release : 2010-02-02 Category : Self-Help ISBN : 1444318861
Addiction Research Methods by Peter G. Miller,John Strang,Peter M. Miller Pdf
Addiction Research Methods’ is a comprehensive handbook for health professionals, policy-makers and researchers working and training in the field of addiction. The book provides a clear, comprehensive and practical guide to research design, methods and analysis within the context of the field of alcohol and other drugs. The reader is introduced to fundamental principles and key issues; and is orientated to available sources of information and key literature. Written by a team of internationally acclaimed contributors, the book is divided into six major sections: Introduction; Research Design; Basic Toolbox; Biological Models; Specialist Methods; and Analytical Methods. Each chapter offers an introduction to the background and development of the discipline in question, its key features and applications, how it compares to other methods/analyses and its advantages and limitations. FEATURES List of useful websites and assistive technology. Case study examples List of useful hermeneutics Recommended reading list Contains exercises to help the reader to develop their skills.
Statistics in Drug Research by Shein-Chung Chow,Jun Shao Pdf
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Cove
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.
Research Methods for Pharmaceutical Practice and Policy by Rajender R. Aparasu Pdf
This text provides the theory and practice for conducting pharmaceutical policy research. It covers all aspects of scientific research from conceptualising to statistical analysis. It also provides scientific basis and a good understanding of the principles and practice of conducting pharmaceutical policy research.
Unique work on structure-based drug design, covering multiple aspects of drug discovery and development. Fully colored, many images, computer animations of 3D structures (these only in electronic form). Makes the spatial aspects of interacting molecules clear to the reader, covers multiple applications and methods in drug design. Structures by mode of action, no therapeutic areas. Of high relevance for academia and industrial research. Focus on gene technology in drug design, omics-technologies computational methods experimental techniques of structure determination multiple examples on mode of action of current drugs, ADME-tox properties in drug development, QSAR methods, combinatorial chemistry, biologicals, ribosome, targeting protein-protein interfaces.
