There are currently over 500.000 types of Medical Devices and in vitro diagnostic medical devices (IVDs) on the EU market [1]. Surgical techniques and Medical Devices may seem...
Epidemiology is the underlying and basic science of public health. It could be defined as any research of health events in populations, including: how many are affected by such...
Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product...
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...
Participant adherence is an essential part of every clinical trial and means ‘the extent to which participants follow the instructions they have been given for participating in the clinical...
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