Glossary

Advisory Committee on Blood Safety and Availability (HHS)

RCHSA(Radiation Control for Health and Safety Act) Accession number (ORA AofC code)

After the IND has been filed, a drug that can be used by patients who are suffering from life-threatening or seriously debilitating conditions, for which no other drug treatment exists, can qualify for accelerated development. Approval can be based on surrogate endpoints or on an FDA determination that the drug can be used safely if distribution is limited

Studies in which the product is stored under stress conditions (for example, 45°C and high humidity over 3-6 months) and observed for signs of degradation; used to predict long-term storage patterns.

(ICH Q1A (R2)) Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at non-accelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes.

A dose that is unlikely to cause an adverse effect in an individual if exposed, by any route, at or below this dose every day for a lifetime. By definition The ADE is protective of all populations by all routes of administration. Normally, the ADE should be based on studies using the same route that it will be applied to evaluate. When this is not possible, and an ADE is required, proper professional should be engaged (toxicologists) to provide a sound scientific rationale to support application to a different route. Only then can the ADE be adjusted to extrapolate between routes which may result in a lower or higher value. As additional information becomes available, the ADE value should be reviewed and revised if necessary.

Results of repeated environmental and/or biological monitoring studies showing no levels above established action levels.

(ICH Q6A) Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures.

The limits of conditions of room critical parameters that may affect the product quality. These conditions may include temperature, humidity, and room air quality. For example, if humidity or particulates are not critical parameters affecting product quality they are not included in acceptance criteria.

(ASTM/PAT) Numerical limits, ranges, process signatures, or other suitable measures that are necessary for making a decision to accept or reject the results of a process, in-process variable, a product or any other convenient subgroups or manufactured units.

(ICH Q7) Numerical limits, ranges, or other suitable measures for acceptance of test results

(IEEE) (ASTM E 2500) The criteria that a system or component must satisfy in order to be accepted by a user, customer or other authorized entity.

The criteria a product must meet to successfully complete a test phase or to achieve delivery requirements.

The criteria a product must meet to successfully complete a test phase or to achieve delivery requirements. This is usually associated with a performance qualification. It may require an exact result (such as the ability of a bar code system to identify correct or incorrect codes) or it may state an acceptable range (such as an incubator demonstrating the ability to maintain a temperature set point plus or minus a given tolerance).

Measurable terms under which a test result may be considered acceptable.

The predetermined result of a specified test.

(ICH Q6B) Numerical limits, ranges or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet.

(IEEE) Testing conducted to determine whether or not a system satisfies its acceptance criteria and to enable the customer to determine whether or not to accept the system.

The regulation of the rate of respiration by the availability of ADP (Adenosine Diophosphate) as phosphate acceptor.

The junction between the right 3' end of an intron and the left end of an exon

(ANSI) To obtain the use of a resource

Device for manipulation of processes, tools, or products within the separative device.

An assembly consisting of panels mounted on pedestals to provide an under-floor space for the installation of mechanical, electrical, communication, or similar systems or to serve as an air-supply or return-air plenum.

(ISO) The time interval between the instant at which a call for data is initiated and the instant at which the delivery of the data is completed.