Glossary

(ICH Q5A (R1)) Intracellularly replicating infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA), are unable to grow and undergo binary fission, and multiply in the form of their genetic material.

A noncellular organism and an intercellular parasite, consisting of nucleic acid (DNA or RNA) in an outer coat of protein. Viruses can live and reproduce only in susceptible host cells; host cells can be bacteria, plant, or animal. The host cell’s synthesis is often inhibited by the infecting virus, which may or may not result in disease (more than 200 viruses are known to produce human disease). An individual virus particle is called a virion, and virions vary in structure, complexity, and size (ranging from 20-25 nm or less to 2,000 nm or more). Six classes of virus are defined by whether they are single or double stranded, DNA or RNA, or positive or negative.

A “genetic parasite”, which attaches a host cell and alters its genetic program so that it produces viruses. Many viruses are completely harmless, while others are lethal. Viruses are so small that they can be seen only under an electron microscope with ten-thousandthfold magnification.

A program which secretly alters other programs to include a copy of itself, and executes when the host program is executed. The execution of a virus program compromises a computer system by performing unwanted or unintended functions which may be destructive.

(ICH Q5A (R1)) Physical separation of virus particles from the intended product.

Particles that resemble retroviruses, yet lack infectivity, and usually are found in established lines of mammalian cells. Cell bank characterization seeks to determine whether viral activity is present, as a means of assessing risk. Not present in non-mammalian cells or cell lines.

(ICH Q5A (R1)) Structures visible by electron microscopy which morphologically appear to be related to known viruses.

A fluid property that relates the magnitude of fluid shear stresses to the fluid strain rate, or more simply, to the spatial rate of change in the fluid velocity field.

Thickness of a liquid; determines its internal resistance to shear forces. The tendency of a fluid to resist flowing because of molecular attraction (cohesion).

The part of the electromagnetic spectrum with wavelengths between 380 nm and 750 nm and perceived by the human eye.

Identification number of the protocol visit for which the investigational products are intended.

Term coined in 1911 (vita, Latin word for life, and the chemical term amine) by polish biochemist, Casimir Funk, represents one of a group of organic substances, some of which are of unknown composition, present in minute amount in natural foodstuffs which are essential to normal metabolism. A lack of vitamins in the diet causes deficiency diseases.Vitamins are commonly classified into two groups, the fat-soluble, and the water-soluble. Vitamins A, D, E, and K are fat-soluble. Vitamin C and members of the vitamin B complex group are water-soluble. In general, the vitamins play catalytic and regulatory roles in the body’s metabolism. Among the water-soluble vitamins, the B vitamins apparently function as coenzymes. Vitamin’s C coenzyme role, if any, has not been established. Part of the importance of vitamin C to the body may result from its strong antioxidant action. The actions of the fat-soluble vitamins are less well understood. Some of them, too, may contribute to enzyme activity, and some of them are essential to the functioning of cellular membranes.

A large group of water soluble vitamins that function as co-enzymes, including thiamine (B1); riboflavin or vitamin G (B2); niacin or nicotinic acid (B3); pantothenic acid (B5); pyridoxine (B6); cyanocobalamin (B12); biotin or vitamin H; folic acid or vitamin M (Bc); inositol; choline; and others.

An enclosure, container, or structure adapted or prepared for keeping or raising and observing animals under semi natural conditions, especially for laboratory research.

Very Large Scale Integration

Value Management

Versatile Micro Analytical Systems

The maximal rate of an enzyme-catalyzed reaction. Vmax is the product of Eo (the total amount of enzyme) times the value of Keat (the catalytic rate constant).

Veterinary Medicines Directorate (United Kingdom)

Validation Master Plan

Silicone Rubber

Virtual Memory System

A short DNA sequence that is present as tandem repeats and in highly variable copy number.

Volatile Organic Compound

A measure of how quickly a substance forms vapors at ordinary temperatures. The more volatile the substance is, the faster it evaporates, and the higher the concentrations of vapor (gas) in the air.