Pivotal StudyA pivotal study is normally a Phase III study of a new intervention which is designed to provide the necessary data for a decision by a regulatory agency.For example, the European Medicines Agency (EMA) requires specific safety and efficacy information about new medicines before it can issue a(...)
PlaceboIn clinical trials, a placebo is a medicine that contains no active ingredients. Placebos have no known medical effects.The 'placebo effect' is a benefit or side effect perceived by patients taking a placebo, despite the fact that no medicine is involved.
Placebo-controlledA placebo-controlled trial is one in which a new medicine is tested against a placebo - a medicine that contains no active ingredients.In placebo-controlled trials, people are assigned to a group (treatment arm) that receives the medicine, or a group that receives the placebo. This is one way(...)
PlasmaPlasma is the fluid part of blood. It contains cells, gases, proteins, enzymes, etc. Unlike blood, plasma is yellow.
PopulationA population is a group of people who share a common trait. For example, they might have a certain disease of interest to researchers, have the same educational background or type of job, or they might live in a particular region.
Population pharmacokineticsPopulation pharmacokinetics is the study of variability in the Absorption, Distribution, Metabolism, and Excretion (ADME) of a medicine between individuals (healthy volunteers or patients). In order to understand how individuals from a population differ from one another, it is necessary to(...)
PosologyThe branch of pharmacology and therapeutics concerned with dosage.
PAESA post-authorisation efficacy study (PAES) may be voluntary or imposed by regulatory authorities. Post-authorisation efficacy studies take place after marketing authorisation is granted and the medicine is in general use. They are Phase IV studies, intended to complement efficacy data that are(...)
Post-authorisation efficacy studyA post-authorisation efficacy study (PAES) may be voluntary or imposed by regulatory authorities. Post-authorisation efficacy studies take place after marketing authorisation is granted and the medicine is in general use. They are Phase IV studies, intended to complement efficacy data that are(...)
PASSA 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(...)
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