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


Mega Sale! Save 21% on the Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines by ACADEMIC PRESS at SADC Network. MPN: Approx. 100 illustrations. Hurry! Limited time offer. Offer valid only while supplies last. 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 e


Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines by ACADEMIC PRESS
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Product Description & Reviews

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

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  • ACADEMIC PRESS

Additional Information

Brand:
ACADEMIC PRESS
Manufacturer:
Academic Press
Category:
Research
MPN:
Approx. 100 illustrations
EAN:
9780128042175
Edition:
2
Part Number:
Approx. 100 illustrations
Author:
Tom Brody PhD
Publisher:
Academic Press
Publication Date:
2016-03-26
Binding:
Hardcover
Item Weight:
6.04 pounds
Item Size:
1.88 x 9.25 x 7.52 inches
Package Weight:
4.5 pounds
Package Size:
7.7 x 1.9 x 9.3 inches

 


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