- 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(...)