Glossary

The intracellular process involved in the synthesis of more complex compounds than those involved in catabolism (for example, glucose to glycogen) and requires energy.

Abbreviated New Animal Drug Application

A microorganism that thrives best, or only, when deprived of oxygen.1.Facultative anaerobe: one able to grow in the presence or absence of free oxygen.2.Obligate or obligatory anaerobe: one that will grow only in the absence of free oxygen.

Growing in the absence of air or oxygen. Some anaerobic organisms are killed by brief exposure to oxygen, whereas it may simply retard or stop the growth of others.

Relating to an anaerobe.

Bacteria capable of growing in the absence of oxygen.

Insensibility to pain without loss of consciousness.

Pertaining to data (signals) in the form of continuously variable (wave form) physical quantities; e.g., pressure, resistance, rotation, temperature, voltage.

A molecule that is either functionally or structurally related to another molecule.

Pertaining to data that consists of continuously variable physical qualities.

(IEEE) A device that operates with variables represented by continuously measured quantities such as pressures, resistances, rotations, temperatures, and voltages.

Input related devices which translate an input device's (sensor) analog signals to the corresponding digital signals needed by the computer.

(ANSI) The methodical investigation of a problem, and the separation of the problem into smaller related units for further detailed study.

A course of reasoning showing that a certain result is a consequence of assumed premises.

To separate into elemental parts or basic principles so as to determine the nature of the whole.

The specific substance to be measured in an assay or analysis.

A generic file format. It was common practice before CFR 21 Part 11 to save information from analytical instruments in this file format. The disadvantage now is that the approach does not allow replaying of data on a different system to yield the same result.

Small-scale process used to characterize and/or separate a mixture, a compound, or an unknown material into its constituent parts or elements.

(ICH Q2 (R1)) The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.

(USP) Detailed description of the steps necessary to perform the assay. The description may include but is not limited to the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the standard curve, use of the formulae for the calculations, etc.

(ASTM E 2500) An instrument designed to measure and report a property of the process, material, or environmental condition.

Absolute Neutrophil Count

also see: Auxiliary Label

Material used in preparing drugs that does not become a component of the drug (e.g. steam, air, N2, DI water).