Quick Guide To Good Clinical Practice: How To Meet International Quality Standard In Clinical Research
by Cemal Cingi /
2016 / English / EPUB
540.8 KB Download
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).
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.
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.
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.
