Books in Clinical trials

Fundamentals of Biologicals Regulation

2nd Edition
November 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
August 11, 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.

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.

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.

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.

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... 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.

An Overview of FDA Regulated Products

1st Edition
June 13, 2018
Eunjoo Pacifici + 1 more
English
Paperback
9 7 8 0 1 2 8 1 1 1 5 5 0
eBook
9 7 8 0 1 2 8 1 1 1 5 6 7

Approx.270 pages

A Comprehensive and Practical Guide to Clinical Trials

1st Edition
June 7, 2017
Delva Shamley + 1 more
English
Paperback
9 7 8 0 1 2 8 0 4 7 2 9 3
eBook
9 7 8 0 1 2 8 0 4 7 3 0 9

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end.

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