Glossary

An inactive ingredient used in the formulation of a drug product.

(ICH Q1A (R2)) Anything other than the drug substance in the dosage form.

(USP) Components of a finished medicinal drug product other than the active pharmaceutical ingredient (API). They are included in the formulation to facilitate manufacture, enhance stability, control release of API from the product, assist in product identification, or enhance other product characteristics.

Factors used to determine whether an individual is ineligible for a trial.

In size-exclusion (or gel filtration) chromatography, a column is packed with a rigid porous gel that has pores the same dimension as the polymer molecule of interest. The exclusion limit is the smallest size of molecule that is too large to enter the pores on the gel particles.

To transport a compound out of a cell. Also known as To Secrete; To Export.

(IEEE) A record of the sequence of instructions executed during the execution of a computer program. Often takes the form of a list of code labels encountered as the program executes. Synonyms: Code Trace, control Flow Trace

Referring to a chemical reaction that takes place with release of negative standard energy to its surroundings, a “downhill” reaction.

Leakage of air out of a room through cracks in doors and pass-throughs through material transfer openings, etc. due to a difference in room pressures.

Air removed mechanically from the space and discarded.

Occurs when absorbents, such as activated carbon or ion exchange resins, have depleted their capacity by using up all active sites. Ion exchange resins may be regenerated to reverse the process.

(NBS) Executing the program with all possible combinations of values for program variables. Feasible only for small, simple programs.

Developing from outside, originating externally. Exogenous factors can be external factors such as food and light that affect an organism.

DNA originating outside an organism that has been introduced into the organism.

A segment of a eukaryotic gene that is transcribed as part of the primary transcript and is retained, after processing, with other exons to form a functional mRNA molecule.

An enzyme that cleaves nucleotides sequentially from free ends of a linear nucleic acid substrate.

A process or chemical reaction that is accompanied by release of heat.

A biological agent where either the corresponding disease does not exist in a given country or geographical area, or where the disease is the subject of prophylactic measures or an eradication program undertaken in the given country or geographical area.

Proteins produced by bacteria that are able to diffuse into a medium through the bacterial cell membrane and cell wall. They are generally more potent and specific in their actions than endotoxins.

Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.

Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. 45CFR46.110

Generally, this refers to an intervention or interaction that is unproven and not yet scientifically validated.