Glossary

The Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as:

• 
  
• How to use the medicine
  
• What the medicine should be used to treat (therapeutic indications)

Danish Health Authority. https://sundhedsstyrelsen.dk"

The endpoint in a clinical trial is an event such as the occurrence of a disease, or symptom, or a particular laboratory result. Once someone reaches the endpoint, they are generally excluded from further research in the trial.

A surrogate endpoint (or marker) is a measure which in itself is not the outcome that the study treatment aims to elicit. For example, blood pressure is used as a surrogate endpoint in trials because it is a risk factor for heart attacks and strokes “ even though in itself blood pressure might not be important for patients.

Surrogate endpoints are useful if it would take a very long time for clinical endpoints to appear. Surrogate endpoints must be proven to be valid markers of clinical endpoints when they are used in clinical trials.

A Suspected Unexpected Serious Adverse Reaction (SUSAR), is a serious adverse reaction (SAR) for which a reasonable causal relationship with the medicine use is suspected but not confirmed. Unexpected in this context means not consistent with the applicable product information (e.g. investigator's brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).

Swiss National Competent Authority. https://www.swissmedic.ch"

This refers to toxic effects caused as a result of absorption and distribution of a substance that affects the whole body rather than a specific (local) area, i.e. to an area distant from its entry point. Most chemicals that produce systemic toxicity do not cause a similar degree of toxicity in all organs, but usually cause major toxicity to one or two organs. These are referred to as the target organs of toxicity for that chemical.

A t-test is a statistical test that helps compare whether the average values of two groups of data are significantly different from each other. It is used to obtain a measure of the difference between the means (averages) of the groups, relative to the spread of data within each group.

The t-test helps decide whether a difference in mean values between two groups is due to random chance in a sample selection.

Refers to the patients the medicine is intended for.

A target product profile is a document that describes the features of a product (such as a medicine) that a company is planning or developing. The document can include a wide range of information such as dosage, how the product will be administered (for example this could be a patient taking a medicine by mouth, or a hospital nurse giving the medicine as an injection), formulation, clinical studies, adverse reactions (unwanted harmful effects) and contraindications (situations when the product should not be used).

The target product profile is written by the company developing the treatment, and if it is begun early it can help keep their development work properly focused on the end goal. A target product profile can also be used as a basis for discussions between the company and those regulatory authorities that will assess the product for release to market.