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Research - Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Description

Book Synopsis: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and moreExtensively covers the “study schema” and related features of study designIncorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trialsIncludes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Details

Are you engaged in clinical trial design and in need of a valuable and practical guide? Look no further than Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. This second edition takes an integrated approach, incorporating biomedical science, laboratory data, legal and regulatory aspects, and much more. With numerous examples and real decisions from FDA reviewers, this book is a must-have resource for anyone involved in clinical trial design. Don't miss out on this comprehensive guide that will enhance your knowledge and skills in designing and conducting clinical trials.

Stay up to date with the latest advancements in clinical trial design with this newly revised edition of Clinical Trials. Packed with new and fully revised material covering key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, and drug regulations in Europe, this book provides comprehensive and in-depth knowledge. Whether you are an early career researcher or a seasoned clinician, this book will equip you with the necessary tools and guidance to make appropriate choices in trial design. Don't let outdated knowledge hinder your progress. Get your copy of Clinical Trials today and stay ahead in the field.

Do you want to have a better understanding of the concepts and fundamentals of clinical trial design? Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is here to help. This book not only provides an overview of design options but also dives deep into the specific details of trial design. The incorporation of laboratory data from studies on human patients makes this book a concrete tool to enhance your understanding. Additionally, you'll gain real-world learning examples from decisions made by FDA reviewers when granting approval of a drug. Don't miss out on the opportunity to improve your knowledge and skills in clinical trial design. Get your hands on Clinical Trials today and take your career to new heights.

Ready to take your clinical trial design skills to the next level? Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is the resource you need. This must-have book covers all aspects of trial design, including the study schema and related features, to ensure you have a comprehensive understanding. With extensive coverage of topics such as drug safety, regulatory approval, and more, you'll be equipped with the knowledge to navigate the complex world of clinical trials. Don't miss out on this opportunity to enhance your skills and make a lasting impact in the field. Get your copy of Clinical Trials today and unlock your full potential!

Ready to dive into the world of clinical trial design? Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is the ultimate guide you've been waiting for. This book offers an integrated approach, combining the biomedical science, laboratory data, legal and regulatory aspects, and more. With updated material on key topics and real-world examples from FDA reviewers, this second edition is a must-have resource for researchers and clinicians alike. Don't wait any longer. Take action now and get your hands on Clinical Trials to elevate your clinical trial design skills!

Get your copy of Clinical Trials today and become an expert in clinical trial design!

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