Glossary

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  • TEAE
    Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.In medicines development terminology, an adverse event (AE) is any undesirable event that(...)
  • Transcriptome
    To produce proteins, genes are first ‘transcribed’ into messenger RNA (mRNA). The transcriptome represents the whole set of mRNA molecules present in a specific cell or tissue at a certain time. By analysing the transcriptome, researchers can determine when each gene is turned on or off in a(...)
  • Transdermal
    Transdermal meaning ‘through the skin’ is a route of medicine administration to deliver a specific dose of medication through the skin and into the bloodstream e.g. transdermal patches or ointments. Examples include nicotine patches and scopolamine patches for motion sickness.
  • Transgenic
    A transgenic organism (otherwise known as a genetically modified organism (GMO)) is an organism whose genetic material has been altered. Genetic modifications are made to produce certain traits (such as disease resistance in crops) or to cause the organism to produce specific biological(...)
  • Translated
    In the field of genetics, translation is the process by which a protein is made from messenger RNA (mRNA). During translation, an RNA sequence is read and translated into the code of amino acids, which are the building blocks of proteins.
  • Treatment Emergent Adverse Event
    Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.In medicines development terminology, an adverse event (AE) is any undesirable event that(...)
  • Treatment group
    In a clinical trial, the treatment group (as opposed to the control group) usually refers to the group of participants that receives the treatment under investigation. The treatment group is also known as the ‘treatment arm’.
  • Type I Error
    Type I Error occurs in statistical hypothesis testing when a null hypothesis, which is actually true, is incorrectly rejected. Type I errors are also known as 'false positives'; they are the detection of a positive effect where no effect actually exists.As a stark example, Type I errors could(...)
  • Type II Error
    Type II Error occurs in statistical hypothesis testing when the null hypothesis is incorrectly accepted. Type II errors are also known as 'false negatives'; they are the failure to detect a positive effect where the effect does exist.Type II errors mean that potentially valuable research goes(...)
  • UAE
    An unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with the summary of product characteristics (SmPC) or, for investigational medicinal products, the applicable product information or characteristics of the medicinal product.
  • UDI
    The Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device; the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can(...)
  • Unexpected Adverse Reaction
    An unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with the summary of product characteristics (SmPC) or, for investigational medicinal products, the applicable product information or characteristics of the medicinal product.
  • Unique Device Identification
    The Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device; the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can(...)

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