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Books in Clinical trials

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Fundamentals of Biologicals Regulation

  • 2nd Edition
  • July 1, 2025
  • Rebecca Sheets + 6 more
  • English
  • Paperback
    9 7 8 - 0 - 4 4 3 - 2 1 9 8 8 - 7
  • eBook
    9 7 8 - 0 - 4 4 3 - 2 1 9 8 9 - 4
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.

Essentials of Translational Pediatric Drug Development

  • 1st Edition
  • July 22, 2024
  • Elke Gasthuys + 3 more
  • English
  • Paperback
    9 7 8 - 0 - 3 2 3 - 8 8 4 5 9 - 4
  • eBook
    9 7 8 - 0 - 3 2 3 - 9 0 4 2 9 - 2
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.

Quality Assurance Management

  • 1st Edition
  • July 20, 2024
  • Gayathri De Lanerolle + 3 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 2 7 3 2 - 9
  • eBook
    9 7 8 - 0 - 1 2 - 8 2 2 7 3 3 - 6
Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.

Clinical Trials and Tribulations

  • 1st Edition
  • March 1, 2023
  • Gayathri De Lanerolle + 2 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 1 7 8 7 - 0
  • eBook
    9 7 8 - 0 - 1 2 - 8 2 1 7 8 8 - 7
Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials.

Laboratory Animal Anaesthesia and Analgesia

  • 5th Edition
  • February 8, 2023
  • Paul Flecknell
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 1 8 2 6 8 - 0
  • eBook
    9 7 8 - 0 - 1 2 - 8 1 8 2 6 9 - 7
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.

The Practical Guide to Clinical Research and Publication

  • 1st Edition
  • August 3, 2021
  • Uzung Yoon
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 4 5 1 7 - 0
  • eBook
    9 7 8 - 0 - 1 2 - 8 2 4 5 1 8 - 7
The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching.

Practical Biostatistics

  • 2nd Edition
  • June 4, 2021
  • Mendel Suchmacher + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 3 2 3 - 9 0 1 0 2 - 4
  • eBook
    9 7 8 - 0 - 3 2 3 - 8 9 8 9 7 - 3
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.

Innovation in Clinical Trial Methodologies

  • 1st Edition
  • November 1, 2020
  • Peter Schueler
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 4 4 9 0 - 6
  • eBook
    9 7 8 - 0 - 3 2 3 - 8 6 0 0 6 - 2
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

  • 1st Edition
  • May 24, 2019
  • Kristine E. Shields
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 1 8 5 5 0 - 6
  • eBook
    9 7 8 - 0 - 1 2 - 8 1 9 0 7 4 - 6
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

  • 1st Edition
  • August 1, 2018
  • Jeff Nelligan
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 1 6 2 4 2 - 2
  • eBook
    9 7 8 - 0 - 1 2 - 8 1 6 2 4 3 - 9
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.com/books-and-journals/book-companion/9780128162422/order-display-posters. 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.