Glossary

Environmental Monitoring System

Process by which a computer imitates the actions of another computer so that the imitating system accepts the same data and executes the same computer programs as the imitated system.

(IEEE) A model that accepts the same inputs and produces the same outputs as a given system.

(IEEE) A model that accepts the same inputs and produces the same outputs as a given system. To imitate one system with another.

(IEEE) A device, computer program, or system that accepts the same inputs and produces the same outputs as a given system.

European Norm

(ICH Q10) A tool or process which provides the means to achieve an objective.

(ICH Q6A) Compounds with the same molecular formula as the drug substance, which differ in the spatial arrangement of atoms within the molecule and are non-superimposable mirror images.

(ICH Q3A (R2)) A compound with the same molecular formula as the drug substance that differs in the spatial arrangement of atoms within the molecule and in a non-superimposable mirror image.

Anything which forms a shell around an enzyme or bacterium, although the agents used are usually polysaccharides such as alginate or agar. The agents are inert and allow nutrients and oxygen to diffuse into and out of the sphere readily, and are easy to convert from gel (solid) to sol (liquid) or solution form by altering the temperature or the concentration of ions.

(IEEE) A software development technique that consists of isolating a system function or a set of data and the operations on those data within a module and providing precise specifications for the module.

Any method of getting something, usually an enzyme or bacterium, into a small package or capsule while it is still working or alive. It is a method for immobilizing cells for use in a bioreactor.

(ANSI) A person, device, program, or computer system that uses an information system for the purpose of data processing in information exchange.

A person whose occupation requires the use of an information system but does not require any knowledge of computers or computer programming.

A disease present in a community or among a group of people; used to describe a disease prevailing continually in a region.

A chemical reaction with a positive standard free energy change; an “uphill” reaction.

The glands that secrete their products (hormones) into the blood that then carries them to their specific target organs. Endocrine glands are the pituitary, thyroids, adrenals, pancreas, ovaries (in females), and testes (in males). Endocrine glands are found in some invertebrates as well as in vertebrates.

The products secreted by the endocrine glands. These help control long-term processes such as growth, lactation, sex cycles, and metabolic adjustment. The endocrine system and the nervous system are interdependent and are often referred to collectively as the neuroendocrine system. For example, the juvenile hormone, found in insects and annelids, affects sexual maturation. There is currently great interest in the possible use of such hormones in the control of destructive insects.

Growing or developing from a cell or organism, or arising from causes within the organism.

(ICH Q5A (R1)) Viral entity whose genome is part of the germ line of the species of origin of the cell line and is covalently integrated into the genome of animal from which the parental cell line was derived. For the purposes of this document, intentionally introduced, non-integrated viruses such as EBV used to immortalize cell substrates or Bovine Papilloma Virus fit in this category.

Duplication of chromosomes without division of the nucleus, resulting in increased chromosome number within a cell. Chromosome strands separate, but the cell does not divide.

A restriction enzyme that cleaves its nucleic acid substrate at internal sites (other than the terminal bonds) in the nucleotide sequence. Microorganisms naturally produce such enzymes as a defense against foreign nucleic acids.

A highly specialized and complex network of branching, interconnecting tubules (surrounded by membranes) found in the cytoplasm of most animal and plant cells. The rough endoplasmic reticulum is where ribosomes make proteins. It appears “rough” because it is covered with ribosomes. The smooth endoplasmic reticulum is the site for synthesis and metabolism of lipids, and it is involved in detoxifying chemicals such as drugs and pesticides.

Endogenous opiates having morphine-like effects consisting of small polypeptides such as enkephalin and leu-enkephalin and longer polypeptides such as alpha-, ß-, and gamma-endorphins. They bind to opiate receptors in the brain. Endorphins induce analgesia when injected intraventricularly but not when administered peripherally, presumably because of their inability to cross the blood/brain barrier. The amino acid sequence of the endorphins is short enough to allow the gene sequences coding for them to be synthesized.

Nutritive tissue that develops in the embryo sac of most angiosperms. It usually forms after the fertilization of the two fused primary endosperm nuclei of the embryo sac with one of the two male gamete nuclei. In most diploid plants, e.g., cereals, the endosperm is triploid (3n), but in some (e.g., lily) it is often consumed as the seed matures.