Glossary Terms (Simple List)
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Membrane Area
The effective surface area of a membrane device that is available for filtration. (TR15)
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Metabolite
A substance that is either the result of metabolism or a requirement for a metabolic process. (TR70)
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Metadata (FDA)
The contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.(TR80)
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Metadata (MHRA)
Metadata is data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).(TR80)
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Metadata (WHO)
Metadata are data about data that provide the contextual information required to understand those data. These include structural and descriptive metadata. Such data describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual.(TR80)
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Method Capability
The resulting acceptable uncertainty of results to achieve the required capability to detect, quantify, and/or discriminate the analyte at levels that is relevant to the intended use. (TR57)
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Method Comparability
The demonstration of analytical method comparability (AMC) for method replacements. A study to demonstrate that a modification to an existing method either improves or does not significantly change the analytical procedure’s characteristics relative to the methods’ validation and intended use. (TR57)
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Method Development
A process that involves the selection, optimization, and qualification of a physical/chemical, biological, molecular, or microbiological test procedure. (TR57)
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Method Lifecycle
All stages in the life of a method, from the initial development through marketing, until the method’s discontinuation. (TR57-2)
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Method Operating Space
Proven acceptable ranges of a method based on knowledge of the effects of critical instrument and procedural parameters on method performance within the design space. (TR57-2)