Glossary

A gene that causes cells to grow in an uncontrolled manner, i.e., that causes cancer. Oncogenes are mutant forms of normal functional genes (called proto-oncogenes) that have a role in normal cell proliferation. Oncogenes are found in tumors and in retroviruses; in the latter case, having been picked up along with retroviral genes during retroviral replication in the host. Once incorporated as part of the retroviral genome, they are activated at inappropriate times and places by retroviral promoters, thereby becoming oncogenes.

The progression of cytological, genetic and cellular changes that culminate in a tumor.

Oncogenic genes are responsible for the transformation of normal cells into tumor cells.

A class of retroviruses that cause a cell to become cancerous.

Office of New Drugs (FDA)

Office of New Drug Chemistry (FDA)

Office of New Drug Quality Assessment (FDA)

Program used with a specific set of data from a single study, (e.g., Clinical Trial).

The egg mother cell; it undergoes two meiotic divisions (oogenesis) to form the egg cell. The primary oocyte is before completion of the first meiotic division; the secondary oocyte is after completion of the first meiotic division.

Object Oriented Programming

Out Of Specification

Out Of Tolerance

Operations

Optical Particle Counter

Open Connectivity

Office of Postmarketing Drug Risk Assessment (CDER) - Renamed ODS

Exposed to the environment.

Platform independent model developed by the Consultative Committee for Space Data Systems (CCSDS). Its aim is to define a common framework of terms and concepts to promote future technical developments in electronic data archiving. Now adopted as published standard ISO 14721: 2003.

For orbital GTAW, a welding head that is open to the atmosphere external to the tube/pipe being welded and that does not enclose the shielding gas, which is still provided through the torch.

An equipment assembly (a process) not meeting the definition of “closed”.

A process when the product, materials, or container/closure sutfaces are exposed to the immediate process environment at a stage/time when such exposure could influence the quality or purity of the product.

A sequence of nucleotides in a DNA molecule that has the potential to encode a peptide or protein: it starts with a start triplet (ATG), is followed by a string of triplets each of which encodes an amino acid, and ends with a stop triplet (TAA, TAG or TGA). This term is often used when, after the sequence of a DNA fragment has been determined, the function of the encoded protein is not known. The existence of open reading frames is usually inferred from the DNA (rather than the RNA) sequence.

Supplies that are packaged and labeled in a way that the identification of the material in the container is visibly displayed on the container label and visible to the dispensing person and intended patient (non-blinded).

Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.