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Market Exclusivity

A fixed period of time during which similar medicines for the same indication as the drug granted market exclusivity, cannot be placed on the market. The EMA grant market exclusivity for a 10-year period after the marketing authorisation of an orphan drug

Marketing authorisation

The approval to market a medicine in one, several or all of the European Union Member States

Markov models

A type of model that assumes that patients move between different health states through the course of their disease. These health states are associated with particular costs and quality of life levels, and the time spent in these health states determines the overall costs and benefits experienced by the patients.


An intermediate or end product of metabolism


Literature mining is the process of extracting facts/data from text in the scientific literature. Literature mining can generate new hypotheses by scrutinising large numbers of publications


A biological or computational system used to simulate a disease or biological process, on which tests are done to describe and explain phenomena that cannot be experienced directly


A group of two or more atoms held together by chemical bonds


Monotherapy is therapy that uses one type of treatment, such as radiation therapy or surgery alone, to treat a certain disease or condition. In drug therapy, monotherapy refers to the use of a single drug to treat a disease or condition.


An analysis approach in which the data sets are multiple 'omes', such as the genome (all of an individual's genes) or proteome (all of an individual's proteins)


A change in a gene.