Books in Clinical trials

Fundamentals of Biologicals Regulation

2nd Edition
October 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, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects 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.This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.

Handbook of Intervention Science

1st Edition
July 1, 2025
Laura N.Gitlin + 1 more
English
Paperback
9 7 8 0 4 4 3 2 1 6 6 4 0
eBook
9 7 8 0 4 4 3 2 1 6 6 5 7

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

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.

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.

Considering the Patient in Pediatric Drug Development

1st Edition
November 19, 2020
Klaus Rose
English
Paperback
9 7 8 0 1 2 8 2 3 8 8 8 2
eBook
9 7 8 0 1 2 8 2 4 2 0 5 6

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.

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 + 1 more
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.

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health