When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the...
Clinical trial results are statistically analysed in terms of demographics, efficacy, and safety. Different types of clinical trial may warrant different interpretations of trial results.
During the non-clinical safety testing step of the medicines discovery and development process, molecules undergo safety testing in animal subjects in order to determine whether or not they are...
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.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III...
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and...
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...
