Glossary

The addition of a known amount of a compound to a standard, sample or placebo, typically for the purpose of confirming the performance of an analytical procedure.

Tests for scale-up of centrifuge processes using graduated test tubes and production scale g-forces.

Small laboratory bioreactors used for the initial growth of mammalian cells lines.

(IEEE) A model of the software development process in which the constituent activities, typically requirements analysis, preliminary and detailed design, coding, integration, and testing, are performed iteratively until the software is complete. Synonymous: Evolutionary Model.

Structured Product Labeling

Location in the DNA sequence where RNA removes the noncoding areas to form a continuous gene transcript for translation into a protein.

During the maturation of eukaryotic mRNA, the process that eliminates intervening intron sequences and covalently joins exon sequences of RNA. (Split Gene; Exon; Guide Sequence). In recombinant DNA technology, the term refers to the latter of the two processes just described, namely joining fragments of DNA together.

An individual, company, institution, or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.

The person or organization that commissions work from third parties. Responsible for work performed by such third parties.

A person or entity that initiates a clinical investigation of a drug — usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The research is defined by a contract. The drug is administered to subjects under the immediate direction of an investigator who is not also a sponsor. A clinical investigator may, however, serve as a sponsor-investigator. The sponsor assumes responsibility for investigating the new drug, including responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.

An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies, or other institutions do not qualify as sponsor-investigators.

1. A reproductive cell that develops into an individual without union with other cells; some spores such as meiospores occur at a critical stage in the sexual cycle, but others are asexual in nature.2. A small, protected reproductive form of a micro-organism, often synthesized when nutrient levels are low.

A bacterial spore is a resistant body formed as part of the lifecycle of some bacteria. Bacterial spores are able to withstand severe environmental conditions (e.g., heat, drying, chemicals) for many years. When conditions are favorable, spores germinate into vegetative bacterial cells capable of replication.

An agent that destroys bacterial and fungal spores.

(USP <1072>) An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative organisms.

An agent that destroys bacterial and fungal spores.

Process by which a material in suspension is converted into droplets that may be coated by a substance, either melted or dissolved in the droplet’s media. The action in spray drying is primarily that of evaporation, energy is applied to the droplet forcing evaporation of the media with both energy and mass transfer through the droplet. Examples of this technology include, pharmaceutical tablet granulation, and rapid drying which results in free-flowing powders on a continuous basis. Spray drying process consists of the following steps:1.Formation of a slurry to be sprayed; this slurry may be a simple concentrated solution or the dispersion of an insoluble material in a solution.2.Liquid atomization into droplets; this action is critical as the droplet size will dictate the equipment size as well as the final product size. There are four types of atomization devices: air, airless, disk (or rotary) spray, and ultrasonic.3.Exposure of the droplet to a heated gas flow; this gas (normally air) supplies the energy required to vaporize the solvent.4.Collection of the dry free-flowing powder or encapsulated liquid or solid.

The main feed channel that connects the mold-filling orifice with the runners leading to each gravity gate. Sprue is also the piece of plastic material formed in this channel.

Structured Query Language

A tube end cut perpendicular to the tangent plane.

Face-to-face perpendicularity.

Standard Reference Manual

Self Reinforcing Polymer

Stainless Steel

Shared Surface Area