Glossary

The therapeutic strategy of targeting structures and cell types other than cancer cells common to all solid tumors as a means to attack a solid tumor.

A translucent, yellowish material of the consistency of glue, less fluid than mucoid or mucinoid, found in the cells and tissues in a state of colloid degeneration or colloid carcinoma.A substance, such as gelatin or cytoplasm that because of the size of its molecules, is slowly diffusible rather than soluble in water and is incapable of passing through an animal membrane.

Particles so fine they will not settle without prior coagulation. They range from 10Å to 1,000Å (Angstroms). They have a net negative charge and readily clog membranes and foul resin beds. Examples are bacteria, silica, and clay.

Examination of the colon through a flexible, lighted instrument called a colonoscope.

A growth of microorganisms on a solid medium. The growth is visible without magnification.

A measure of the number of bacteria present in the environment or on the surface of an aseptic processing room; measured as part of qualification and ongoing monitoring.

A measure of the number of bacteria present in the environment or on the surface of an aseptic processing room; measured as part of qualification and ongoing monitoring. Also applied to the testing of purified water samples.

A group of lymphokines that induce the maturation and proliferation of white blood cells from the primitive cell types present in bone marrow.

A vertical, cylindrical container or vessel used to separate vapor-liquid or liquid-liquid systems by extraction, distillation, or chromatography.

The number that expresses the result of calculating the length of a chromatography column divided by its width.

A separation method in which the different components of a mixture migrate through a column at different rates of speed based on their various chemical properties.

Control of Major Accident Hazards Regulations 1999

(ICH Q6A) A drug product which contains more than one drug substance.

(FDA) (1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

A product discovery technique that uses robotics and parallel synthesis to generate and screen quickly as many as several million molecules with similar structure in order to find chemical molecules with desired properties.

A multicomponent preparation formulated so that different antigens are administered simultaneously. The different antigenic components are intended to protect against different strains or types of the same organism and/or different organisms. A combined vaccine may be supplied by the manufacturer either as a single liquid or freeze-dried preparation or as several constituents with directions for admixture before use.

Able to catch on fire and burn.

Any finely divided solid material that is 420µ or 0.017 inches or less in diameter, or any material capable of passing through an US No. 40 standard sieve that when dispersed in air in the proper proportions, could be ignited by a flame, spark or other source of ignition.

The National Fire Protection Association (NFPA) and the U.S. Department of Transportation (DOT) generally define combustible liquid as a liquid having a closed cup flash point at or above 100°F (37.8°C). Combustible liquids do not include compressed gases or cryogenic fluids. Combustible liquids are subdivided as follows:1.Class II - Liquids having a closed cup flash point at or above 100°F (37.8°C) and below 140°F (60°C)2.Class III-A - liquids having a closed cup flash point at or above 140°F (60°C) and below 200°F (93.3°C)3.Class III-B - liquids having a closed cup flash point at or above 200°F (93.3°C).

Center-wide Oracle Management Information System

(IEEE) Information embedded within a computer program, job control statements, or a set of data, that provides clarification to human readers but does not affect machine interpretation.

(ISO) In programming languages, a language construct that allows [explanatory] text to be inserted into a program and that does not have any effect on the execution of the program.

(FDA – 2011) The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term “commercial manufacturing process” does not include clinical trial or treatment IND material.

(IEEE) Software defined by a market-driven need, commercially available, and whose fitness for use has been demonstrated by abroad spectrum of commercial users.

The blending of carry-over material from one grade of an excipient with another, usually due to a continuous process.