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Clinical Trials - Study Design, Endpoints And Biomarkers, Drug Safety, And FDA And Ich Guidelines (Cód: 9238311)

Brody,Tom

Academic Press

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Clinical Trials - Study Design, Endpoints And Biomarkers, Drug Safety, And FDA And Ich Guidelines

R$325,20

Descrição

'Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines' is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the 'study schema' and related features of study designOffers a 'hands-on' reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial designFeatures examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study designIntegrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trialsIncludes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http: //tinyurl.com/awwutvn

Características

Peso 1.44 Kg
Produto sob encomenda Não
Marca Academic Press
I.S.B.N. 9780123919113
Referência 016759024
Altura 23.11 cm
Largura 19.56 cm
Profundidade 3.81 cm
Número de Páginas 638
Idioma Inglês
Acabamento Capa dura
Cód. Barras 9780123919113
Ano da edição 2011
AutorBrody,Tom