Glossary Terms (Simple List)
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Reference Strain
A well characterized, widely accepted preparation of viable organisms that is used to validate a microbiological assay. (TR50)
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Regeneration
Operation performed to remove residual proteins, impurities, or contaminants from the resin. [Synonym: strip] (TR14)
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Registration Stability Lots
The lots of drug substance manufactured to establish the stability profile in support of the regulatory filing. (TR56)
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Regression
A mathematical model in which the response of a dependent variable is a function of change in an independent variable, such as is seen in a concentration-response curve. Regression may be linear (e.g., a straight line) or non-linear (e.g., four parameter logistic). (TR57)
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Rejection
The ability of a filter to exclude solutes or particulate matter from passing through. (TR45)
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Relative Accuracy
Attribute determined after demonstration of precision, linearity, and specificity under deliberately varied conditions, such as across a range of sample dilutions in the presence of matrix interference. (TR57-2)
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Relevant Virus
A virus used in process evaluation studies that either is the identified virus, or of the same species as the virus known to or likely to contaminate the cell substrate or any other reagents or materials used in the production process. (TR41)
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Repeatability
The precision under the same operating conditions over a short interval of time. (TR57)
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Replicates
Independent preparations of a sample or standard that are subject to the same treatment conditions. (TR57)
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Reportable result
The final analytical result. This result is defined in the written approved test method and derived from one full execution of that method, starting from the original sample. (TR57)