Glossary

A 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 to improve the chances that any benefit experienced by the treatment group receiving the medicine is due to the active ingredient in that medicine rather than some other factor.

Plasma is the fluid part of blood. It contains cells, gases, proteins, enzymes, etc. Unlike blood, plasma is yellow.

A 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 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 perform population pharmacokinetic analysis.

The branch of pharmacology and therapeutics concerned with dosage.

A 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 regulatory decision making.

A post authorisation safety study might be a clinical trial or a non-interventional study, and can be created voluntarily by the MAH, or can be required by the regulator (imposed™). The Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) is responsible for assessing the protocols of imposed studies and for assessing the studies™ results. The EMA publishes the protocols and abstracts of the final study reports online.

Post marketing refers to the period after a medicine has been granted marketing authorisation and is available for general use.

A 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 available at the time of the initial authorisation, and gather long-term data about how well the medicine works when used widely.

A 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 information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when it is used widely.

"An 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 observed in clinical trials or epidemiological studies for which the difference compared with the control group raises a suspicion of an association, but is not large enough to suggest a causal relationship"