Glossary

A vehicle that is required for dosing of the IMP or NIMP, but may or may not be provided by the sponsor. This includes, but is not limited to, saline, sterile water for injection, glucose, etc.

Analysis of Covariance

Abbreviated New Drug Application Number (ORA AofC code)

Abbreviated New Drug Application

Analytical Data Interchange

Any hormone that stimulates the development of male secondary sexual characteristics, and contributes to the control of sexual activity in vertebrate animals. Usually synthesized by the testes.

A device that measures air speed.

Loss of sensation with or without loss of consciousness.

A joint between two members located in intersecting planes between 0 deg. (a butt joint) and 90 deg. (a corner joint).

A unit of length equal to one hundred-millionth of a centimeter (one ten-thousandth of a micron) used especially to specify radiation wavelengths. Equal to 0.1 nanometers.

Free from water and especially water crystallization.

(WHO) Products and/or ingredients derived from tissues or secretions of animals susceptible to Transmissible Spongiform Encephalopathies (TSEs), primarily cattle’s Bovine Spongiform Encephalopathy (BSE). This definition applies to all substances or preparations obtained from such animals and to all substances or preparations where products obtained from such animals are included as active substances, excipients or adjuvants or have been used in production as raw or source materials, starting materials or reagents (e.g., bovine serum albumin; enzymes; culture media including those used to prepare working cell banks for medicinal products), or those utilized in the preparation/finishing of product contact surfaces in equipment or system components.

A laboratory animal useful for medical research because it has specific characteristics that resemble a human disease or disorder. Scientists can create animal models, usually laboratory mice, by transferring new genes into them.

Before researchers test pharmaceuticals in human clinical trials, they test them in animals to determine toxicity, dosing and efficacy. What they learn in animal models helps them determine if it is safe and worthwhile to proceed to human trials, and how best to design those trials.

Analytical Information Mark-up Language

A negatively charged particle or ion having fewer protons than electrons.

A negatively charged atom or group of atoms. Anions have more electrons (negatively charged) than protons (positively charged) which gives them a net negative charge.

An ion exchange material that removes anions from solution by exchanging them with hydroxyl ions.

Sampling condition in which the mean velocity of the air entering the sample probe inlet is significantly different from the mean velocity of the unidirectional airflow at that location.