Glossary

Also known as side chain. The group of atoms that differs among the 20 types of amino acid molecules and thus determines their diverse chemical properties; for example, the R subgroup on a glycine molecule is simply a hydrogen atom, on an alanine it is a methyl complex (a carbon and three hydrogens), and on glutamine it is a combination of carbon, oxygen, nitrogen, and hydrogen atoms.

Research and Development

Regulatory Authority

Arithmetic Average Roughness

Rinsed Area

Restricted Access Barrier System

Regulatory Affairs Committee (ISPE term)

Recombinant DNA Advisory Committee (NIH Guidelines)

(ICH Q6A) A composite (solid, liquid, gaseous, or in solution) of equimolar quantities of two enantiomeric species. It is devoid of optical activity.

Responsible, Accountable, Consulted, Informed

Matrix that defines who will do the work and be responsible for its completion (R), who will remain accountable for the completion of the work (A), who should be consulted as the work is being progressed (C), and who should be informed of the work upon completion (I).

Reasonably Available Control Technology

Rapid Application Development

Sterilization using gamma radiation emitted from radioactive materials such as cobalt-60, or cesium 137. If proper dosage of nuclear radiation can be documented, sterility testing is not required.

An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members. 21 CFR 36.1

An unstable isotope that emits ionizing radiation.

A material or combination of materials that spontaneously emits ionizing radiation.

High frequency electromagnetic waves that emanate from electronic devices such as chips and other electronic devices. An electromagnetic disturbance caused by such radiating and transmitting sources as electrostatic discharge (ESD), lightning, radar, radio and TV signals, and motors with brushes can induce unwanted voltages in electronic circuits, damage components and cause malfunctions.

A method of detecting imperfections in materials by passing X-ray or nuclear radiation through the material and presenting their image on a recording medium.

A nondestructive method of internal examination in which metal objects are exposed to a beam of X-ray or gamma radiation. Differences in thickness, density or absorption, caused by internal defects or inclusions, are apparent in the shadow image either on a fluorescent screen or on photographic film placed behind the object.

A highly sensitive method of detecting and measuring the concentration of biological compoundsIn vivo.

A sensitive method for detecting and measuring trace amounts of a biomolecule based on its ability to displace a radioactive version of itself from combination with its specific antibody.

Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. These materials are largely physiological or subpharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body.

Substance that prevents or lessens the effects of radiation.