Glossary

Point or region where DNA replication is begun. Often abbreviated Ori.

A manufacturer of computer hardware.

Office of Review Management (CDER)

Office of Regional Operations (FDA)

Oxidation Reduction Potential

The FDA grants Orphan Drug status to one company for a drug that is believed to substantially increase the life expectancy of the treated patient for a particular disease. This excludes other companies from receiving an FDA license to produce a similar drug for a finite period (usually 7 years), thereby allowing the company producing the drug to recuperate their R&D expenses.

Provisions of the Orphan Drug Act Congress passed the Orphan Drug Act of 1983 to stimulate the development of drugs for rare diseases. Prior to passage of this historic legislation, private industry had little incentive to invest money in the development of treatments for small patient populations, because the drugs were expected to be unprofitable. The law provides three incentives:(1) 7-year market exclusivity to sponsors of approved orphan products(2) A tax credit of 50 percent of the cost of conducting human clinical trials(3) Federal research grants for clinical testing of new therapies to treat and/or diagnose rare diseases. In 1997, Congress created an additional incentive when it granted companies developing orphan products an exemption from the usual drug application or “user” fees charged by the Food and Drug Administration (FDA). Companies also may be eligible for faster review of their applications for marketing approval if their products treat a life-threatening illness. Many orphan drugs treat a serious or life-threatening disease. Congress amended the Act in 1984, 1985, and 1988. The 1984 amendment defined a rare disease as a condition affecting fewer than 200,000 people in the United States. The threshold was an arbitrary ceiling based on the estimated prevalence of narcolepsy and multiple sclerosis. The 1985 amendment extended marketing exclusivity to patentable as well as unpatentable drugs, and the 1988 amendment required sponsors to apply for orphan designation before submitting an application for marketing approval.

As applied to viral removal processes, a recognizably different approach from the other processes used for viral removal/inactivation.

Operating System (computers)

Oral Solid Dosage

Occupational Safety and Health Administration (United States)

Federal agency in the U.S. Department of Labor that establishes workplace safety and health regulations. Many states, including California, have their own OSHA programs. State OSHA programs are monitored by federal OSHA to ensure that they are “at least as effective as” the federal OSHA program.

Office of Statewide Health Planning and Development (California)

Open Systems Interconnection

The value obtained by dividing the molar concentrations of a solute by the number of ions formed in the dissociation of the solute in question; convenient in handling problems involving osmotic pressure.

The concentration of osmotically active particles in a solution (expressed in osmols of solute per liter of solution). Osmosis is flow through a semipermeable membrane. Osmotic pressure is the pressure that must be applied to a solution to prevent osmosis. Osmotic shock is rapid change in osmotic pressure of a cell or virus, usually causing it to discharge its contents.

The total molar concentration of the solutes. Osmolarity affects the osmotic potential of solution or nutrient medium.

The diffusion of a solvent through a semipermeable membrane from a solution of higher concentration to one of lower concentration until there are equal concentrations of fluid on both sides of the membrane.

The passage of water through a permeable membrane separating two solutions of different concentrations; the water passes into the more concentrated solution.

Potential brought about by dissolving a substance, especially in water.

Pressure generated by the osmotic flow of water through a membrane into a (aqueous) phase containing a solute in a higher concentration.

Oil Spill Prevention and Response Act

Open Source Software

Over The Counter (Medicine)