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Handbook of Epidemiology

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information.Presents parametric and nonparametric statistical techniques.Describes adequate methods for power and sample size determination.Includes appropriate presentation of results from bioequivalence studies.Provides a practical overview of the design and analysis of bioequivalence studies.Presents the recent developments in methodology, including population and individual bioequivalence.Reviews the regulatory guidelines for such studies, and the existing global discrepancies.Discusses the designs and analyses of drug-drug and food-drug interaction studies.Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.

Building on the success of the first and second editions, the updated third edition of the Handbook of Epidemiology serves as a major reference for all researchers who want to conduct epidemiological studies or who want to deepen their understanding of epidemiological concepts, methods, and areas of application. The new edition provides an update of all chapters of the second edition and includes additional new chapters to account for recent developments in the field. The book provides a comprehensive overview of the field and covers basic approaches as well as novel and advanced methodologies with a strong applied focus by integrating the most relevant state-of-the-art knowledge that otherwise could only be gathered from single specialist publications dispersed over various scientific journals. It reviews the key issues and methodological approaches pertinent to the field for which the reader pursues an expatiated overview. It may thus serve both as a firstorientation for the interested reader and as a starting point for an in-depth study of a specific area as well as a quick reference and a recapitulatory update for the expert.The broad scope of the book becomes apparent by its five sections that facilitate an integration of epidemiological concepts and methods, statistical tools, applications, and epidemiological practice: Part I covers Concepts and Designs in Epidemiology; Part II, Methodological Approaches in Epidemiology; Part III, Statistical Methods in Epidemiology; Part IV, Exposure-Oriented Epidemiology; and Part V, Outcome-Oriented Epidemiology. All chapters follow a similar structure and highlight cross-references to related topics and specialist knowledge to be found in the Handbook. They give an overview of the topic and the most important problems and approaches that are illustrated by examples. Each chapter serves as an introductory text that helps to enter a new field by addressing basic concepts without being too elementary. Thus, it also is of interest for readers who are familiar with the particular topic by reflecting on its state-of-the-art and future perspectives. Each chapter stands on its own and comprises introductory elements that can be understood by the novice, i.e., a readership not being too familiar with the methodological background, and extends to in-depth knowledge that may serve as a reference for the trained epidemiologist. The standard procedures and methods, basic concepts, and knowledge are presented as well as recent advances and new perspectives. The list of references thus covers the whole range from introductory texts to publications for the advanced reader. In particular, the chapters on statistical methods are written for researchers in health sciences who do not have the background of theoretical statisticians and may be in need of application-oriented tools. These chapters offer numerous examples, practical applications, and illustrations. Handbook of Epidemiology, 3rd Edition, is a relevant resource for professionals involved in health research, health reporting, health promotion, disease prevention, health services, and health systems administration, as well as those who need a reference book that covers all aspects of epidemiology as a comprehensive consultant for specific topics. The Handbook also is a useful text for researchers and graduate students in all disciplines related to epidemiology and public health.

Despite adults’ best preventive efforts, childhood obesity is on the rise in most areas of the world, and with it the prevalence of Type 2 diabetes, hypertension, cardiovascular disease, and other formerly adult-onset conditions. Epidemiology of Obesity in Children and Adolescents takes the global ecological approach that is needed to understand the scope of the problem and its multiple causes and mechanisms, and to aid in developing more effective prevention and intervention programs. In the book’s first half, experts present a descriptive summary of youth obesity trends in ten world regions, broken down by age group, gender, socioeconomic status, and risk factors. Complementing these findings, part two reviews the evidence base regarding the variables, separately and in combination, having the most significant impact on young people’s development of obesity, including:• Genetic and nutrigenomic factors.• Environmental and psychosocial factors, such as family shopping and eating habits and access to healthful foods.• Neuroendocrine regulation.• Prenatal and neonatal factors (e.g., gestational diabetes of the mother).• Dietary factors, from nutrient content to young people’s food preferences.• Physical activity versus sedentary behavior.Epidemiology of Obesity in Children and Adolescents is necessary reading for the range of professionals involved in curtailing this epidemic, including public health specialists, epidemiologists, pediatricians, nurses, nutritionists, psychologists, health educators, and policymakers.

Complementing these findings, part two reviews the evidence base regarding the variables, separately and in combination, having the most significant impact on young people’s development of obesity, including:• Genetic and nutrigenomic factors.

In young children, questionnaires have to be completed by proxies, usually their parents, while older children, particularly adolescents, can provide a major part of the requested information themselves.This book presents suitable designs, methods and instruments for data collection in studies of children and adolescents.

With chapters on user-centered technology development, evaluation, participatory approaches in digital public health, and global digital public perspectives, it also presents examples taken from ten essential public health operations.

In young children, questionnaires have to be completed by proxies, usually their parents, while older children, particularly adolescents, can provide a major part of the requested information themselves.This book presents suitable designs, methods and instruments for data collection in studies of children and adolescents.

Dieses Lehrbuch liefert eine umfassende Darstellung der deskriptiven und induktiven Statistik sowie moderner Methoden der explorativen Datenanalyse. Dabei stehen inhaltliche Motivation, Interpretation und Verständnis der Methoden im Vordergrund. Unterstützt werden diese durch zahlreiche Grafiken und Anwendungsbeispiele, die auf realen Daten basieren, sowie passende exemplarische R-Codes und Datensätze. Die im Buch beschriebenen Ergebnisse können außerdem anhand der online zur Verfügung stehenden Materialien reproduziert sowie um eigene Analysen ergänzt werden. Eine kurze Einführung in die freie Programmiersprache R ist ebenfalls enthalten. Hervorhebungen erhöhen die Lesbarkeit und Übersichtlichkeit. Das Buch eignet sich als vorlesungsbegleitende Lektüre, aber auch zum Selbststudium.Für die 9. Auflage wurde das Buch inhaltlich überarbeitet und ergänzt. Leserinnen und Leser erhalten nun in der Springer-Nature-Flashcards-App zusätzlich kostenfreien Zugriff auf über 100 exklusive Lernfragen, mit denen sie ihr Wissen überprüfen können.