Practical Guide to Human Research and Clinical Trials

Inbunden, Engelska, 2013

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Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

Produktinformation

Utgivningsdatum2013-01-29
Mått156 x 234 x 24 mm
Vikt725 g
FormatInbunden
SpråkEngelska
Antal sidor350
FörlagTaylor & Francis Inc
ISBN9781466591172

Tillhör följande kategorier

Tillverkningsteknik inom Naturvetenskap och teknik
Biologi inom Naturvetenskap och teknik
Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin

Forewords, Preface, Chapter 1 Clinical Research - A Clinical Investigator's Perspective Chapter 2 Medical Device Development, Process and Regulation Chapter 3 Pre-Clinical Drug Development Chapter 5 Phase ) Microdosing Studies Chapter 6 Clinical Research Planning Chapter 7 Clinical Research Design Chapter 8 Clinical Research Protocol Chapter 9 Designing Case Report Forms Chapter 10 Process of Randomisation in Clinical Trials Chapter 11 Investigational Medical Products Chapter 12 Multi-centre Clinical Trials Chapter 13 Good Clinical Research Practice Chapter 14 Role and Responsibilities of Sponsor Chapter 15 Role and Responsibilities of Principal Investigator Chapter 16 Ethical Considerations in Clinical Research – Special References to Developing Countries Chapter 17 Informed Consent in Clinical Research Chapter 18 Monitoring in Clinical Trials Chapter 19 Quality Assurance in Clinical Research Chapter 20 Pharmacovigilance and Drug Safety Chapter 21 Data and Safety Monitoring Board and Monitoring Plan Chapter 22 Standard Operating Procedures Chapter 23 Archiving Clinical Research Documents Chapter 24 Evidence Based Medicine Chapter 25 Clinical Research Data management Chapter 26 Clinical Biostatistics, Glossary