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'Me too' medicine

˜Me too™ medicines are products which have more or less identical clinical outcomes to existing medicines. They are compounds structurally very similar to already known medicines that have an identical mechanism of action with only minor pharmacological differences. They can present some benefits, like providing more therapeutic options and in a few cases lead to price reductions, but also involve disadvantages, like diminishing innovation in pioneering treatments.



In pharmacology and pharmacokinetics, absorption is the process whereby medicines are transported or taken up from the site of administration (by mouth, inhalation, intravenous or intramuscular injection, etc.) to the blood through capillary, osmotic, solvent, or chemical action in the cells. This could be through the intestinal wall, skin, or mucous membranes.

In specific situations, such as intravenous (IV) therapy, absorption is straightforward and there is less variability, because the medicine goes directly in to the bloodstream. In the case of IV injection, the bioavailability of the compound is 100%.

Absorption is a primary focus in medicines development, as a compound must first be absorbed before any medicinal effects can take place. Moreover, the medicine™s pharmacokinetic profile can be significantly changed by factors that affect absorption.

Acquired Immunodeficiency Syndrome (AIDS)

Acquired Immunodeficiency Syndrome (AIDS) is the group of conditions that develop during the advanced stage of  infection with the human immunodeficiency virus (HIV). People at this stage of HIV disease have badly damaged immune systems, which puts them at risk of infection. Patients frequently develop infections and tumours that do not usually affect people who have healthy immune systems.

Active molecule

In medicines R&D an active molecule is a chemical compound that has pharmacological or biological activity likely to be therapeutically useful.

Adaptive Design

The option to modify the design of an ongoing clinical trial is becoming increasingly common and is known as adaptive design. Data are evaluated before the trial is finished. This is known as interim analysis and might be carried out at several time points. Depending on the circumstances, this may lead to changes to the trial such as stopping one treatment arm or changing the number of participants in a group. The planned number of participants might be reduced if the interim analysis shows that a smaller sample size will still allow a valid result to be obtained. Alternatively, the sample size might be increased if that will allow a valid or reliable result to be obtained within a more acceptable period of time.

Adaptive designs can save time and resources, and can reduce the exposure of study participants to the inferior treatment.

Interim analyses and any anticipated changes to a trial should be described and justified in the study protocol.


Adenoviruses are medium-sized viruses. They cause a wide range of illnesses in the lungs, stomach, intestines, and eyes, from mild respiratory infections in young children to life-threatening multi-organ disease in people with a weakened immune system. Adenoviruses are used in research as vehicles for gene therapy and vaccines.


In medicine, adherence describes the degree to which a patient correctly follows medical advice. Poor adherence is often associated with patients not following prescribed medicines and treatment regimes. Non-adherence or poor adherence has been reported as a major problem in medical practice and can also affect the outcomes of a clinical trial. Poor adherence, or failure to follow treatment instructions, may be attributed to a number of reasons such as poor communication, forgetfulness, or unpleasant side-effects.

Efforts to improve adherence in clinical practice have included simplifying medication packaging, providing medication reminders, improving patient education, and limiting the number of medications prescribed simultaneously. Various measures of adherence are used in clinical trials, for instance: the assessment of pharmacological response, electronic diaries, residual tablet count, devices to monitor tablet removal from containers, testing for medicine in blood or urine, or the use of pharmacological markers/indicators.


An adjuvant is a substance (pharmacological and/or immunological) that modifies the effect of other substances or medicines. Immunological adjuvants may be added to vaccines to boost the immune response. Adjuvant therapy or care is therapy that is given in addition to the main or initial therapy to maximise its effectiveness. For example, radiotherapy is commonly given as adjuvant treatment after surgery for breast or other cancers.

Advanced therapy medicinal products

Advanced therapy medicinal products (ATMP) are new medical products for human use based on genes (gene therapy), cells (cell therapy), or tissues (tissue engineering). They have huge potential and open the way for new treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer, or muscular dystrophy.

Adverse Drug Reaction

A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility.


Adapted from the Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 3) 2014.

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