Global clinical trials : effective implementation and management /

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a w...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Chin, Richard, Bairu, Menghis
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Amsterdam ; Boston : Academic Press, �2011.
Temas:
Clinical trials > Developing countries.
Human experimentation in medicine > Developing countries.
Clinical Trials as Topic
Clinical trials
Human experimentation in medicine
Developing countries
Acceso en línea:Texto completo

MARC

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245 0 0 |a Global clinical trials :  |b effective implementation and management /  |c Richard Chin, Menghis Bairu [editors]. 
260 |a Amsterdam ;  |a Boston :  |b Academic Press,  |c �2011. 
300 |a 1 online resource (xx, 501 pages, [13] pages of color plates) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
520 |a This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA. 
505 0 |a Introduction Section I: Overview -- Section II: Clinical Study and Logistics -- Section III: Special Considerations in Conducting Trials in Developing Countries. 
588 0 |a Print version record. 
650 0 |a Clinical trials  |z Developing countries. 
650 0 |a Human experimentation in medicine  |z Developing countries. 
650 2 |a Clinical Trials as Topic  |0 (DNLM)D002986 
650 7 |a Clinical trials  |2 fast  |0 (OCoLC)fst00864429 
650 7 |a Human experimentation in medicine  |2 fast  |0 (OCoLC)fst00963042 
651 7 |a Developing countries  |2 fast  |0 (OCoLC)fst01242969 
700 1 |a Chin, Richard. 
700 1 |a Bairu, Menghis. 
776 0 8 |i Print version:  |a Chin, Richard.  |t Global Clinical Trials.  |d Academic Press  |z 9780123815378  |w (OCoLC)711573741 
856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9780123815378  |z Texto completo 

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