Glossary Terms (Simple List)
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D-value (D10 -Value)
The time in minutes required for a one-logarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. (TR51)
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Dwell Time
The period that items are subjected to a given processing condition. [Synonym: Residence Time] (TR3)
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Dynamic (in operation)
BFS machine line fully operational and filling, with the number of allowed operating personnel present as during normal running conditions. (TR77)
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Dynamic Light Scattering (DLS)
A technique used to measure the size and size distribution of particles. Particles suspended in a solution will cause scattering of light and the extent of the scattering is related to the size and shape of the particles. (TR47)
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Dynamic Monitoring
Monitoring of an environment during normal operations, that is, when the usual equipment is operating and personnel are present, and the process or simulated process is ongoing. Per the EU and ISO documents this is synonymous with operational condition (including the equipment operating and personnel present). (TR13)
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Dynamic Record Format (FDA)
The record format allows interaction between the user and the record content.(TR80)
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Dynamic Record Format (MHRA)
An electronic record which the user reviewer can interact with.(TR80)
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Dynamic Record Format (WHO)
Records, such as electronic records, that allow for an interactive relationship between the user and the record content.(TR80)
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Early Phase
Generally used to indicate Phase 1 and A clinical studies.(TR 56)
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Early Phase (Generally used to indicate the following clinical study activities)
Generally used to indicate the following clinical study activities: Microdosing Studies, Phase 1 Trials, Phase 2 Trials, and Phase 3 Trials. See any of the following studies for more information. (TR56)