Post Authorisation Safety StudyA post authorisation safety study is a study carried out after a medicine has been given a marketing authorisation. Its purpose is to obtain further safety information or to assess how well risk-management measures are working. The information from a post authorisation safety study is used in(...)
Post marketingPost marketing se refera la perioada de dupa primirea autorizatiei de comercializare a unui medicament, cand acesta este deja disponibil pentru pacienti.
Post-marketing surveillance studyA post-marketing surveillance study (PMS study), also known as a Phase IV study, may be voluntary or imposed by the regulatory authorities. They are conducted after marketing authorisation is granted and the medicine is in general use. Post-marketing surveillance studies collect additional(...)
PMSA post-marketing surveillance study (PMS study), also known as a Phase IV study, may be voluntary or imposed by the regulatory authorities. They are conducted after marketing authorisation is granted and the medicine is in general use. Post-marketing surveillance studies collect additional(...)
Potential riskAn unexpected event for which there is suspicion of an association with a medicinal product, but where this association has not been confirmed. Some examples are: toxicological findings seen in non-clinical safety studies which have not been observed in clinical studies; adverse events(...)
PowerA term often used in clinical research is statistical power. The power of a statistical test is the ability of the test to detect an effect, if the effect actually exists. In statistical terms, it is the probability that it will correctly lead to the rejection of a null hypothesis.In some(...)
PrecursorA substance or cellular component from which another substance or cellular component is formed.
Predictive genetic testA predictive genetic test is a genetic test in a person without symptoms to predict future risk of disease. This testing allows early identification of individuals at risk of a specific condition, which can lead to reduced risk through targeted screening and prevention. For example, a woman(...)
Predictive MedicinePredictive medicine is a field of medicine that predicts the probability of disease. When an individual is predicted to have a high risk of a disease, preventive measures can be started in order to either prevent the disease altogether or significantly decrease its impact upon the patient.(...)
PredisposedSomeone who is predisposed to a disease is more likely than other people to develop the disease in the future.For example, someone who is genetically predisposed to develop Alzheimer's has a genetic makeup that increases their risk of developing this disease. A predisposition will not in(...)
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