Glossary

Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness.

A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation.

The group that receives the investigational treatment in a trial; the group to which the control group results are compared.

(ICH Q1A (R2)) The date placed on the container label of a drug product designating the time prior to which a batch of the product is expected to remain within the approved shelf life specification if stored under defined conditions, and after which it must not be used

The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.

(ICH Q7) The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions, and after which it should not be used.

Tangible information captured in documents, databases, websites, etc.

A release of energy sufficient to cause a pressure wave; a rapid or sudden release of energy that causes a pressure discontinuity or blast wave.

A type of construction used to house solvents in sufficiently large quantities, to qualify the space electrically as an explosion potential area. Typically the internal walls, ceiling, and floor are constructed of material strong enough to withstand a specified intensity of explosion and at least one wall has explosion relief devices that direct the explosion outwardly. In a single story arrangement, or if the explosion resistant area is on the top floor, the roof may also have devices that can be used to relieve the explosion.

(OSHA) A chemical that causes a sudden, almost instantaneous release of pressure, gas and heat when subjected to sudden shock, pressure, or high temperatures.

A material or chemical, other than a blasting agent, that is commonly used or intended for the purpose of producing an explosive effect.

The range of concentrations (% by volume in air) of a flammable gas or vapor that can result in an explosion from ignition in a confined space. Usually given as Upper (UEL) and Lower Explosive Limits (LEL).

The drug substance is exposed to the room environment during processing.

Contact with a substance by swallowing, breathing, or touching the skin or eyes. Exposure may be short-term, of intermediate duration, or long-term.

To translate the genetic information stored in the DNA (gene) into a specific protein.

A short strand of DNA (~200 base pairs), which is part of copy DNA (double-stranded DNA complement of a messenger RNA sequence for protein expression); usually unique to each particular cDNA, so it can be used to help identify unknown genes and map their position in a genome.

In biology, expression is the transcription of the genetic information contained in a gene by synthesis of a messenger RNA molecule and the subsequent synthesis of a protein. In genetic engineering, expression is the production of a protein by introduction of a foreign gene into microorganisms or cell cultures.

In genetics, manifestation of a characteristic that is specified by a gene. With hereditary disease, for example, a person can carry the gene for the disease but not actually have the disease. In this case, the gene is present but not expressed. In industrial biotechnology, the term is often used to mean the production of a protein by a gene that has been inserted into a new host organism.

(ICH Q5B) The expression vector which contains the coding sequence of the recombinant protein and the elements necessary for its expression.

A host organism combined with a genetic vector (such as virus or circular DNA molecule called a plasmid) that is loaded with a gene of interest. The expression system provides the genetic context in which a gene will function in the cell – that is, the gene will be expressed as a protein.

A cloning vector that has been constructed in such a way that, after insertion of a DNA molecule, its coding sequence is properly transcribed and the RNA is translated. The cloned gene is put under the control of a promoter sequence for the initiation of transcription, and often also has a transcription termination sequence at its end. Such promoters are termed high level; examples include P1 (the leftward promoter of phage l) and the promoter of the yeast PGK (Phosphoglycerate Kinase) gene.

The second half of the ACSII character set, 128 thru 255. The symbols are defined by IBM for the PC and by other vendors for proprietary use. It is non-standard ASCII.

An eight-bit code used to represent specific data characters in some computers; e.g., IBM mainframe computers.

(ICH Q6A) Products which are formulated to make the drug available over an extended period after administration.