Method development and validation pdf

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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. A test method is a method for a test in science or engineering, such as a physical test, chemical test, or statistical test.

It is a definitive procedure that produces a test result. A test can be considered a technical operation or procedure that consists of determination of one or more characteristics of a given product, process or service according to a specified procedure. Often a test is part of an experiment. It can be a personal observation or the output of a precision measuring instrument.

Usually the test result is the dependent variable, the measured response based on the particular conditions of the test or the level of the independent variable. Some tests, however, may involve changing the independent variable to determine the level at which a certain response occurs: in this case, the test result is the independent variable.

In software development, engineering, science, manufacturing, and business, it is vital for all interested people to understand and agree upon methods of obtaining data and making measurements. It is common for a physical property to be strongly affected by the precise method of testing or measuring that property. It is vital to fully document experiments and measurements and to provide needed definitions to specifications and contracts.