Glossary

Inventory Management Agreement

Irish Medicines Board

International Mechanical Code

Immunodiffusion

A prefix denoting a compound containing the bivalent atom group (NH).

(ICH Q1B) That constituent of the packaging that is in direct contact with the drug substance or drug product, and includes any appropriate label.

(ICH Q6A) Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug.

To alter cells (either chemically or genetically) so that they can reproduce indefinitely.

The production of antibodies (humoral response) or particular types of cytotoxic lymphoid cells (cell-mediated response) on challenge with an antigen.

The combination of cells, biological substances (such as antibodies) and cellular activities that work together to provide resistance to disease.

The state of an organism in which protection from many infectious diseases is afforded by prior exposure to the infectious agents.

The production of immunity in an individual by artificial means. Active immunization involves the introduction, either orally or by infection, of specially treated bacteria, viruses or their toxins so as to stimulate the production of antibodies.

The separation of different antigen-antibody systems by diffusion in an agar gel; a separate precipitation band in the gel detects each system.

Technique for identifying substances based on the use of antibodies.

The use of specific antibodies to measure a substance. This tool is useful in diagnosing infectious diseases and the presence of foreign substances in a variety of human and animal fluids (blood, urine, etc.). It is currently being investigated as a way of locating tumor cells in the body.

Technique for identifying antigenic material that uses an antibody labeled with fluorescent material. Specific binding of the antibody and antigen can be seen under a microscope by applying ultraviolet light rays and noting the visible light that is produced.

A substance that is capable of causing antibody formation – that is, the body recognizes it as a foreign agent that must be expelled or destroyed.

A substance capable of evoking an immune response.

A protein produced by plasma cells that fights infection or takes part in various immune responses. Immunoglobulins bind with other molecules with a high degree of specificity; divided into five classes (IgA, IgD, IgE, IgG, and IgM) on the basis of structure and biological activity.

A member of a class of proteins that functions as an antibody. The wide range of different specifities of antibodies depends on subtle differences in their structure.

A class of serum proteins rich in antibodies. Often used, along with the more specific monoclonal antibodies, in diagnostic reagents in the health field.

The body’s first line of defense against infectious diseases and is present in seromucous secretions such as saliva, tears, nasal fluids, sweat and secretions of the lung and genito-urinary and gastro-intestinal tracts.

A major class of immunoglobulins found in the blood, including many of the most common antibodies circulating in the blood.