Clinical Trials

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Autor: Tom Brody

Jazyk:

Väzba: Pevná

Vydavateľ: Elsevier Science Publishing Co Inc

Dostupnosť: U vydavateľa na objednávku

Odosielame za 28-34 dní

93.13 €

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practi...

Informácie o knihe

Autor

Tom Brody

Jazyk

Angličtina

Väzba

Kniha - Pevná

Vydalo

2016

Stránok

896

EAN

9780128042175

ISBN

0128042176

Enbook ID

02843599

Vydavateľ

Elsevier Science Publishing Co Inc

Hmotnosť

1894

Rozmery

243 x 201 x 49

Kompletný popis

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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Clinical Trials

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

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