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Elsevier

Libros en Ensayos Clínicos

  • A Comprehensive Guide for the Novice Researcher in Clinical Trials

    • 1 Edición
    • Miltiadis Lytras + 2 más
    • Inglés
    A Comprehensive Guide for Novice Researcher in Clinical Trials is a must-have resource for individuals embarking on the journey of clinical research. This book is tailored for beginners, offering a clear and structured introduction to the vital principles, methodologies, and skills required to design and conduct robust clinical trials. Spanning 13 chapters, it meticulously covers the entire clinical trial process, emphasizing Good Clinical Practice (GCP) standards. From foundational research concepts to advanced trial strategies, the guide empowers readers to confidently navigate the complexities of clinical trials and contribute meaningfully to the field of healthcare.In addition to its foundational content, the book addresses a variety of important topics, such as ethical considerations, regulatory compliance, and the development of trial protocols. It explores different trial designs, types of bias, and the historical evolution of clinical research. Practical sections on data management, monitoring, statistical analysis, and project management offer readers hands-on guidance for real-world application. Notably, the book includes a dedicated focus on regulatory affairs in Saudi Arabia, making it particularly valuable for health professionals in that region.

  • Fundamentals of Biologicals Regulation

    Vaccines and Biotechnology Medicines
    • 2 Edición
    • Rebecca Sheets + 6 más
    • Inglés
    This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions with emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

  • Handbook of Intervention Science

    From Design to Implementation
    • 1 Edición
    • Laura N.Gitlin + 1 más
    • Inglés
    Handbook of Intervention Science: From Design to Implementation discusses multiple approaches for developing and advancing interventions at the individual, family, community, health system, and policy level. The book focuses on creating interventions suitable for diverse populations from racial, ethnical, geographical, and socioeconomical perspectives. Combining best practices with a practical approach, the book enables readers to advance their intervention research. It covers intervention design, data capture in trials, and evaluation. Decision trees help illustrate when to move forward with an implementation relative to the need for further work.

  • Essentials of Translational Pediatric Drug Development

    From Past Needs to Future Opportunities
    • 1 Edición
    • Elke Gasthuys + 3 más
    • Inglés
    Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population.

  • Laboratory Animal Anaesthesia and Analgesia

    • 5 Edición
    • Paul Flecknell
    • Inglés
    Laboratory Animal Anaesthesia and Analgesia, Fifth Edition provides a basic guide to anesthesia for a very diverse audience involved in animal testing. This has been the go-to resource for current, clear and evidence-based information for over 30 years. The book is divided into four parts that deal with preparation for anesthesia, including definitions, equipment, preparations, anesthetic and analgesic agents, the management and monitoring of anesthesia, including pre-procedural preparations, monitoring and problems and emergencies through the procedure, advanced and specialized techniques, and analgesia and post-operative care, including recovery and the prevention and management of post-operative pain. Final sections cover anesthesia in common laboratory species, specifically: rodents, rabbits, cats, dogs, ferrets, pigs, sheep and goats, primates, reptiles, amphibians and new specific chapters on birds, fish and cephalopods. This edition keeps up with the tradition of bringing a balanced dose of practical advice, foundational content, and current, updated references, drugs and procedures to veterinarians, technicians, researchers and ethics committee personnel.

  • Practical Biostatistics

    A Step-by-Step Approach for Evidence-Based Medicine
    • 2 Edición
    • Mendel Suchmacher + 1 más
    • Inglés
    Practical Biostatistics: A Step-by-Step Approach for Evidence-Based Medicine, Second Edition presents a complete resource of biostatistical knowledge meant for health sciences students, researchers and health care professionals. The book's content covers the investigator’s hypothesis, collective health, observational studies, the biostatistics of intervention studies, clinical trials and additional concepts. Chapters are written in a didactic way, making them easier to comprehend by readers with little or no background on statistics. Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision-making using statistical analyses of scientific methods and outcomes to drive further experimentation and diagnosis. With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or hands-on guide on how to effectively incorporate biostatistics in clinical trials and research projects.

  • Considering the Patient in Pediatric Drug Development

    How Good Intentions Turned Into Harm
    • 1 Edición
    • Klaus Rose
    • Inglés
    Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

  • Innovation in Clinical Trial Methodologies

    Lessons Learned during the Corona Pandemic
    • 1 Edición
    • Peter Schueler
    • Inglés
    Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design.

  • Pregnancy and the Pharmaceutical Industry

    The Movement towards Evidence-Based Pharmacotherapy for Pregnant Women
    • 1 Edición
    • Kristine E. Shields
    • Inglés
    Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities. Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.

  • The Sourcebook for Clinical Research

    A Practical Guide for Study Conduct
    • 1 Edición
    • Jeff Nelligan + 1 más
    • Inglés
    A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier... Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.