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Observational adequacy. The theory achieves an exhaustive and discrete enumeration of the data points. There is a pigeonhole for each observation. Descriptive adequacy. The theory formally specifies rules accounting for all observed arrangements of the data. The rules produce all and only the well-formed constructs (relations) of the protocol ...
In analytical chemistry, the detection limit, lower limit of detection, also termed LOD for limit of detection or analytical sensitivity (not to be confused with statistical sensitivity), is the lowest quantity of a substance that can be distinguished from the absence of that substance (a blank value) with a stated confidence level (generally 99%).
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.
Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. [5] Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness.
Also acid ionization constant or acidity constant. A quantitative measure of the strength of an acid in solution expressed as an equilibrium constant for a chemical dissociation reaction in the context of acid-base reactions. It is often given as its base-10 cologarithm, p K a. acid–base extraction A chemical reaction in which chemical species are separated from other acids and bases. acid ...
Level 2 – Potential Application Validated Level 3 – Proof-of-Concept Demonstrated, Analytically and/or Experimentally Level 4 – Component and/or Breadboard Laboratory Validated Level 5 – Component and/or Breadboard Validated in Simulated or Realspace Environment Level 6 – System Adequacy Validated in Simulated Environment
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
Layers of protection analysis (LOPA) is a technique for evaluating the hazards, risks and layers of protection associated with a system, such as a chemical process plant. . In terms of complexity and rigour LOPA lies between qualitative techniques such as hazard and operability studies (HAZOP) and quantitative techniques such as fault trees and event trees.