There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment. David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.

Mismeasurement of explanatory variables is a common hazard when using statistical modeling techniques, and particularly so in fields such as biostatistics and epidemiology where perceived risk factors cannot always be measured accurately. With this perspective and a focus on both continuous and categorical variables, Measurement Error and Misclassification in Statistics and Epidemiology: Impacts and Bayesian Adjustments examines the consequences and Bayesian remedies in those cases where the explanatory variable cannot be measured with precision.

The author explores both measurement error in continuous variables and misclassification in discrete variables, and shows how Bayesian methods might be used to allow for mismeasurement. A broad range of topics, from basic research to more complex concepts such as "wrong-model" fitting, make this a useful research work for practitioners, students and researchers in biostatistics and epidemiology."

Cancers are on the rise across the world. Except for viral-based cancers, overall cancers are diseases that may be preventable. This book looks at the many levels of determined, probable, and possible causation for several common cancers. These causes include realities found in culture, anthropology, sociology, politics, the environment, agriculture and food, beliefs, and the modern lifestyle. These realities are filtered through the perennial science of Chinese medicine - an ecological system of knowing and understanding the human body as it relates to the world around us.The book covers lung, colorectal, breast, prostate, and virally-caused cancers. It interweaves conventional medical knowledge of these cancers with modern realities of everyday life we all live, and with Chinese medicine interpretations and strategies for treating probable pre-cancerous conditions. This makes it a book that is useful for the practitioner of Chinese medicine. It is also useful for the patient suffering a cancer diagnosis in terms of survivorship and for other medical practitioners who wish to understand how integrated care for cancerous diseases and conditions may relate to Chinese medicine and prevention.The final chapters of the book are dedicated to finding answers for a cure for cancer through making connections between how we live, what we believe, the environment we are creating based on those beliefs, and the social and political mechanisms we now have in place that keep us from change and, therefore, from the cure for cancer.

Written by experts in the analytical chemistry of tobacco smoke, Tobacco Smoke Exposure Biomarkers summarizes the toxicology, metabolic pathway, and biomarkers of nicotine, TSNAs, PAHs, VOCs, AAs, Catechol and Hydroquinone, HCN, CO and NOx, and heavy metals, and the use of this biomarker in exposure assessment and/or cigarette smoke exposure environmental epidemiology. A convenient one-stop guide, the book brings together information on some exposure biomarkers and nicotine addiction in humans with regulatory implications and strategies. The authors also include discussions of how smoke exposure biomarkers may be used to shape regulation and health policy. Ethics guidelines, details of method development, and the validated relative bioanalytical method provided in the appendixes rounds out the coverage. The book gives you tools to further research biomarkers for tobacco carcinogens and to face emerging health challenges such as delivery of nicotine via electronic cigarettes.

Recent decades have seen a steady rise in the incidence of antisocial behavior in youth. Possible direct consequences aside, such behavior is predictive of chronic emotional, educational, vocational, and emotional impairment that is associated with hundreds of millions of dollars in costs to overtaxed mental health, social services, special education, and juvenile justice systems. Written by an eminent group of international experts, Conduct and Oppositional Defiant Disorders: Epidemiology, Risk Factors, and Treatment offers the first comprehensive cutting-edge overview of all the major aspects of conduct disorder (CD) and oppositional defiant disorder (ODD) in children and adolescents. It is organized into three sections. The first summarizes classification and assessment, epidemiology and comorbidity, as well as course and outcome. The second examines factors that put children and adolescents at risk to develop CD and ODD: contextual, familial/genetic, and neuropsychological and neuroendocrine. The third presents numerous empirically supported approaches to prevention and treatment. An epilogue reviews recent progress and unresolved questions, and suggests needs for future research. Special attention is devoted to gender and developmental pathways in etiology, symptom expression, courses, and outcomes. This volume will be crucial reading for all mental health professionals whose work involves them with these exceptionally difficult clients.

Collecting and analyzing data on unemployment, inflation, and inequality help describe the complex world around us. When published by the government, such data are called official statistics. They are reported by the media, used by politicians to lend weight to their arguments, and by economic commentators to opine about the state of society. Despite such widescale use, explanations about how these measures are constructed are seldom provided for a non-technical reader. This Measuring Society book is a short, accessible guide to six topics: jobs, house prices, inequality, prices for goods and services, poverty, and deprivation. Each relates to concepts we use on a personal level to form an understanding of the society in which we live: We need a job, a place to live, and food to eat. Using data from the United States, we answer three basic questions: why, how, and for whom these statistics have been constructed. We add some context and flavor by discussing the historical background. This book provides the reader with a good grasp of these measures. Chaitra H. Nagaraja is an Associate Professor of Statistics at the Gabelli School of Business at Fordham University in New York. Her research interests include house price indices and inequality measurement. Prior to Fordham, Dr. Nagaraja was a researcher at the U.S. Census Bureau. While there, she worked on projects relating to the American Community Survey.

THE GROUNDBREAKING, FORMATIVE WORK IN SPATIAL EPIDEMIOLOGY - NOW UPDATED FOR A NEW GENERATION OF RESEARCH AND PRACTICE IN PUBLIC HEALTH In 2003, Neighborhoods and Health codified the idea that a neighborhood's social and physical makeup can influence the health of people who live in it. More than a decade later, with the relationship between place and health firmly entrenched at the center of how we understand public health (and as its own scientific discipline, spatial epidemiology), this second edition of the landmark text offers another giant leap forward for the field. Offering both a synthesis of the essential research and a practical overview of the methods used to garner it, the second edition of Neighborhoods and Health is the essential guide to understanding this core component of contemporary population health - both the journey to date and what's next.

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

How to apply statistical methods to survey data—a guide to effective analysis of health surveys.

With large health surveys becoming increasingly available for public use, researchers with little experience in survey methods are often faced with analyzing data from surveys to address scientific and programmatic questions. This practical book provides statistical techniques for use in survey analysis, making health surveys accessible to statisticians, biostatisticians, epidemiologists, and health researchers. The authors clearly explain the theory and methods of survey analysis along with real-world applications. They draw on their work at the National Institutes of Health as well as up-to-date information from across the literature to present:

• The sampling background necessary to understand health surveys.
• The application of such techniques as t-tests, linear regression, logistic regression, and survival analysis to survey data.
• The use of sample weights in survey data analysis.
• Dealing with complications in variance estimation in large health surveys.
• Applications involving cross-sectional, longitudinal, and multiple cross-sectional surveys, and the use of surveys to perform population- based case-control analyses.
• Guidance on the correct use of statistical methods found in software packages.
• Extensive bibliography.

Multilevel modelling facilitates the analysis of hierarchical data where observations may be nested within higher levels of classification. In health care research, for example, a study may be undertaken to determine the variability of patient outcomes where these also vary by hospital or health care region. Inference can then be made on the efficacy of health care practices.

• Focuses on multilevel modelling for health and medical research
• Covers the majority of analytical techniques required by health care professionals
• Repeated measures, outliers, institutional performance and spatial analysis are all examined in a multilevel framework
• All the methodology is applied to data sets relating to the health of individual or populations
• Includes in-depth discussion of the software packages used in multilevel modelling

Health care professionals and public health researchers interested in the application of statistics will benefit greatly from this text. It will also be of interest to postgraduate students studying medical statistics.

Key Topics in Clinical Research aims to provide a short, clear, highlighted reference to guide trainees and trainers through research and audit projects, from first idea, through to data collection and statistical analysis, to presentation and publication. This book is also designed to assist trainees in preparing for their specialty examinations by providing comprehensive, concise, easily accessible and easily understandable information on all aspects of clinical research and audit.

This monograph on vertigo is based on the personal, hands-on, practical and clinical experience of managing vertigo in a large university-affiliated hospital. It covers all aspects of the subject, offering the latest information on epidemiology, aetiopathogenesis, diagnostics, the battery of vestibular and allied tests, treatment, rehabilitative management and ethical considerations. The neglected but substantial problem of paediatric vertigo is addressed, as are the many pathologies in the elderly population that can lead to disequilibrium and repeated falls. This book will prove of value to a range of practitioners, including family physicians, otologists, audiologists, vestibular scientists, neurologists, paediatricians, geriatricians, physiotherapists, rehabilitation therapists and general doctors, as well as medical and nursing students.

Cancers are on the rise across the world. Except for viral-based cancers, overall cancers are diseases that may be preventable. This book looks at the many levels of determined, probable, and possible causation for several common cancers. These causes include realities found in culture, anthropology, sociology, politics, the environment, agriculture and food, beliefs, and the modern lifestyle. These realities are filtered through the perennial science of Chinese medicine - an ecological system of knowing and understanding the human body as it relates to the world around us.The book covers lung, colorectal, breast, prostate, and virally-caused cancers. It interweaves conventional medical knowledge of these cancers with modern realities of everyday life we all live, and with Chinese medicine interpretations and strategies for treating probable pre-cancerous conditions. This makes it a book that is useful for the practitioner of Chinese medicine. It is also useful for the patient suffering a cancer diagnosis in terms of survivorship and for other medical practitioners who wish to understand how integrated care for cancerous diseases and conditions may relate to Chinese medicine and prevention.The final chapters of the book are dedicated to finding answers for a cure for cancer through making connections between how we live, what we believe, the environment we are creating based on those beliefs, and the social and political mechanisms we now have in place that keep us from change and, therefore, from the cure for cancer.

This book is dedicated to Dr. Philip A. Schwartzkroin. The book has a novel format because it is not intended to be a set of reviews. Instead, it is an effort to explore important topics in the epilepsy research field. Because articles are written by leaders in the field who have years of experience, and individuals with diverse expertise, articles are likely to have a long-lasting impact and be relevant for both epileptologists and neuroscientists. Authors address topics that are important, unresolved questions in the field of epilepsy research, drawing on available data from both the bench and the clinic to support their points. A given topic is addressed by one or more authors, each writing from his/her own unique perspective. For all of the individuals who have been trained or worked with Philip Schwartzkroin in the past, and/or have appreciated his contributions to the epilepsy field, this volume is an excellent way to celebrate his achievements and look to the ways they have moved the field forward, and continue to stimulate its growth.

This work provides current models, tools, and examples for the formulation and evaluation of scientific hypotheses in causal terms. It introduces a new method of model parametrization, and illustrates structural equations and graphical elements for complex causal systems.

Computational Genomics with R provides a starting point for beginners in genomic data analysis and also guides more advanced practitioners to sophisticated data analysis techniques in genomics. The book covers topics from R programming, to machine learning and statistics, to the latest genomic data analysis techniques. The text provides accessible information and explanations, always with the genomics context in the background. This also contains practical and well-documented examples in R so readers can analyze their data by simply reusing the code presented. As the field of computational genomics is interdisciplinary, it requires different starting points for people with different backgrounds. For example, a biologist might skip sections on basic genome biology and start with R programming, whereas a computer scientist might want to start with genome biology. After reading: You will have the basics of R and be able to dive right into specialized uses of R for computational genomics such as using Bioconductor packages. You will be familiar with statistics, supervised and unsupervised learning techniques that are important in data modeling, and exploratory analysis of high-dimensional data. You will understand genomic intervals and operations on them that are used for tasks such as aligned read counting and genomic feature annotation. You will know the basics of processing and quality checking high-throughput sequencing data. You will be able to do sequence analysis, such as calculating GC content for parts of a genome or finding transcription factor binding sites. You will know about visualization techniques used in genomics, such as heatmaps, meta-gene plots, and genomic track visualization. You will be familiar with analysis of different high-throughput sequencing data sets, such as RNA-seq, ChIP-seq, and BS-seq. You will know basic techniques for integrating and interpreting multi-omics datasets. Altuna Akalin is a group leader and head of the Bioinformatics and Omics Data Science Platform at the Berlin Institute of Medical Systems Biology, Max Delbruck Center, Berlin. He has been developing computational methods for analyzing and integrating large-scale genomics data sets since 2002. He has published an extensive body of work in this area. The framework for this book grew out of the yearly computational genomics courses he has been organizing and teaching since 2015.

Finite element analysis has been widely applied to study biomedical problems. This book aims to simulate some common medical problems using finite element advanced technologies, which establish a base for medical researchers to conduct further investigations. This book consists of four main parts: (1) bone, (2) soft tissues, (3) joints, and (4) implants. Each part starts with the structure and function of the biology and then follows the corresponding finite element advanced features, such as anisotropic nonlinear material, multidimensional interpolation, XFEM, fiber enhancement, UserHyper, porous media, wear, and crack growth fatigue analysis. The final section presents some specific biomedical problems, such as abdominal aortic aneurysm, intervertebral disc, head impact, knee contact, and SMA cardiovascular stent. All modeling files are attached in the appendixes of the book. This book will be helpful to graduate students and researchers in the biomedical field who engage in simulations of biomedical problems. The book also provides all readers with a better understanding of current advanced finite element technologies. Details finite element modeling of bone, soft tissues, joints, and implants Presents advanced finite element technologies, such as fiber enhancement, porous media, wear, and crack growth fatigue analysis Discusses specific biomedical problems, such as abdominal aortic aneurysm, intervertebral disc, head impact, knee contact, and SMA cardiovascular stent Explains principles for modeling biology Provides various descriptive modeling files

Cannabis Physiopathology and Detection features an outstanding collection of contributions from leading researchers around the world. Papers were presented at the Second International Colloquium on Illicit Drugs, held at the French National Academy of Medicine in April 1992. The book reviews the latest clinical reports describing the effects of cannabis on the brain (imaging techniques, memory and psychomotor performance, cannabis, and schizophrenia), effects on reproduction (male and female), and carcinogenicity. Aspects of detection covered in the volume include methods, results of different testing groups, and legal issues associated with testing and detection. Cannabis Physiopathology and Detection will be an important addition to the reference collections of marijuana researchers, pathologists, government agencies, medical school libraries, and drug testers.

Covering all major arthropods of medical importance worldwide, this award-winning resource has established itself as a standard reference for almost 25 years. With the globilization of commerce and the world becoming more intimately connected through the everyday ease of travel, unknown arthropod species are being increasingly encountered. This means access to up-to-date, authoritative information in medical entomology has never been more important. Now in its seventh edition, this book maintains its well-acclaimed status as the ultimate easy-to-use guide to identify disease-carrying arthropods, the common signs and symptoms of vector-borne diseases, and the current recommended procedures for treatment. Includes an in-depth chapter with diagnostic aids to help physicians to recognize and accurately diagnose arthropod-related diseases and conditions more easily Updates all chapters with the latest medical and scientific findings, including Zika virus, red meat allergy, new viruses found in ticks, and vaccine development for malaria and dengue fever Presents a greater medical parasitology emphasis throughout Offers electronic downloads containing additional photographs of arthropod-caused diseases and lesions, as well as instructional videos with pest identification aids, basic entomology, and insect and pest ecology. Illustrated throughout with detailed color images to aid identification, The Goddard Guide to Arthropods of Medical Importance, Seventh Edition will remain an essential guide for physicians, public health officials, and pest control professionals.

This book provides an engaging, jargon-free introduction to the threat of global pandemics, offering an overview of the many origins and triggers of pandemic events. It covers the impacts generated by novel infectious disease outbreaks across various dimensions - from social and ethical to medical and political, from media to economic and legal implications. The author discusses the preparedness strategies developed globally, the lessons learned from various outbreaks and the mitigation measures deployed - from quarantine and social distancing to data sharing and surveillance systems - including their unintended impacts. While the risk of global pandemics is certainly intensely debated by the scientific community, and increasingly by policy makers at various levels, the threat is hardly discussed in the public domain. It only permeates the media during crisis events, such as during the SARS outbreak in 2003, the West African Ebola outbreak in 2014-15, and most notably the ongoing COVID-19 global pandemic crisis. This book is thus highly timely and topical. It has a global scope, whilst at times zooming in on the implications of pandemic risk and mitigation for the Global North or the Global South. Given the interdisciplinarity of the topic, this book will be of great interest to a wider non-academic audience, as well as students from a range of subjects including politics, sociology, geography, anthropology, and international development, along with entry-level medical students keen to widen their appreciation of the social dimensions of the medical work they set out to conduct.

Contagion - even today the word conjures up fear of disease and plague and has the power to terrify. The nine essays gathered here examine what pre-modern societies thought about the spread of disease and how it could be controlled: to what extent were concepts familiar to modern epidemiology present? What does the pre-modern terminology tell us about the conceptions of those times? How did medical thought relate to religious and social beliefs? The contributors reveal the complexity of ideas on these subjects, from antiquity through to the early modern world, from China to India, the Middle East, and Europe. Particular topics include attitudes to leprosy in the Old Testament and the medieval West, conceptions of smallpox etiology in China, witchcraft and sorcery as disease agents in ancient India, and the influence of classical Greek medical theory. An important conclusion is that non-medical perceptions are as crucial as medical ones in people's beliefs about disease and the ways in which it can be combatted. Today we may not believe in the power of demons, but the idea that illness is retribution for sin retains great power, as was shown by the popular reaction to the spread of AIDS/HIV, and this is a lesson from the past that the medical profession would do well to heed.

Cost-effectiveness analysis is becoming an increasingly important tool for decision making in the health systems. Cost-Effectiveness of Medical Treatments formulates the cost-effectiveness analysis as a statistical decision problem, identifies the sources of uncertainty of the problem, and gives an overview of the frequentist and Bayesian statistical approaches for decision making. Basic notions on decision theory such as space of decisions, space of nature, utility function of a decision and optimal decisions, are explained in detail using easy to read mathematics. Features Focuses on cost-effectiveness analysis as a statistical decision problem and applies the well-established optimal statistical decision methodology. Discusses utility functions for cost-effectiveness analysis. Enlarges the class of models typically used in cost-effectiveness analysis with the incorporation of linear models to account for covariates of the patients. This permits the formulation of the group (or subgroup) theory. Provides Bayesian procedures to account for model uncertainty in variable selection for linear models and in clustering for models for heterogeneous data. Model uncertainty in cost-effectiveness analysis has not been considered in the literature. Illustrates examples with real data. In order to facilitate the practical implementation of real datasets, provides the codes in Mathematica for the proposed methodology. The motivation for the book is to make the achievements in cost-effectiveness analysis accessible to health providers, who need to make optimal decisions, to the practitioners and to the students of health sciences. Elias Moreno is Professor of Statistics and Operational Research at the University of Granada, Spain, Corresponding Member of the Royal Academy of Sciences of Spain, and elect member of ISI. Francisco Jose Vazquez-Polo is Professor of Mathematics and Bayesian Methods at the University of Las Palmas de Gran Canaria, and Head of the Department of Quantitative Methods. Miguel Angel Negrin is Senior Lecturer in the Department of Quantitative Methods at the ULPGC. His main research topics are Bayesian methods applied to Health Economics, economic evaluation and cost-effectiveness analysis, meta-analysis and equity in the provision of healthcare services.

The human foetus is separated from the maternal blood by the syncytiotrophoblast induced by endogeneous human retrovirus-encoded proteins. This barrier is a highly developed one, which suppors apical-basolateral transport of maternal idiotype and anti-idiotype IgG, IgG-virus complexes. The selective maternal-fetal transport of epitope- and paratope-bearing entities can influence the developping fetal immune system during pregnancy. The bidirectional maternal-fetal transfer of cells are of even more importance during pregnancy. Maternal cells with latent viruses transport viruses without impairment of fetal development. Cells with premaligant and malignant genetic transformation are also transported to the fetus. Fetal and neonatal tumours are initiated by such cells in spite of the antitumour potential of fetal organism. On the contary, the fetal cells repair maternal tissue injouries and survive in the organisms of the recipients for decades. These possess new consequences for the neonatal immunity and organ transplatation surgery.

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

This captivating study tells Mexico's best untold stories. The book takes the devastating 1833 cholera epidemic as its dramatic center and expands beyond this episode to explore love, lust, lies, and midwives. Parish archives and other sources tell us human stories about the intimate decisions, hopes, aspirations, and religious commitments of Mexican men and women as they made their way through the transition from the Viceroyalty of New Spain to an independent republic. In this volume Stevens shows how Mexico assumed a new place in Atlantic history as a nation coming to grips with modernization and colonial heritage, helping us to understand the paradox of a country with a reputation for fervent Catholicism that moved so quickly to disestablish the Church.