EAN: 9783319443430

QUICK GUIDE TO GOOD CLINICAL PRACTICE - CEMAL C...

This brand-new book offers a reference guide to understanding and applying the rules for
properly conducting clinical trials to meet the international quality standard - Good Clinical
Practice - provided by the International Conference on Harmonization (ICH). The work offers an
updated perspective on the clinical research landscape within the context of the clinical trial
regulatory frameworks in Europe and the USA. In addition to providing a historical review and a
detailed definition of GPC regulations  it includes step-by-step explanations of all the
requirements that researchers should bear in mind when designing and performing new trials.
Further topics covered include: ethics of clinical research  the drug development process and
evolution of regulations  investigator and sponsor responsibilities  and clinical trial
protocols.Written by clinicians for clinicians  the book represents a valuable read also for
researchers  pharmacists and all professionals involved in applications to the ethic committees
whose approval is required for new clinical studies.

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