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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 more. Extensively covers the "study schema" and related features of study design. Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials. Includes decisions made by FDA reviewers when granting approval of a drug as real-world learning examples for readers.

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Details

Looking to enhance your knowledge and expertise in clinical trial design? Look no further than Clinical Trials: Study Design, Endpoints and Biomarkers. This comprehensive second edition delves deep into the intricacies of trial design, offering an integrated approach that incorporates biomedical science, regulatory guidelines, and more. Packed with real-world examples and insights from FDA reviewers, this book is the go-to resource for researchers and clinicians looking to elevate their clinical trial design skills.

With new and fully revised material on key topics such as biostatistics, biomarkers, and drug regulations, Clinical Trials provides a comprehensive overview of the design options available to researchers. Whether you're an early-career researcher or a seasoned professional, this book offers practical guidance on making informed choices and crafting effective trial designs that meet regulatory standards and drive successful outcomes.

Take your clinical trial design skills to the next level with Clinical Trials: Study Design, Endpoints and Biomarkers. Gain valuable insights into study schema, laboratory data integration, and regulatory approval processes. Don't miss out on this must-have resource that equips you with the knowledge and tools needed to excel in the fast-paced world of clinical research.

Ready to dive into the world of clinical trial design and unlock a wealth of knowledge? Get your copy of Clinical Trials: Study Design, Endpoints and Biomarkers now!

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