ASTM E 2617 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Practice for Validation of Empirically Derived Multivariate Calibrations
Hardcopy , PDF
11-11-2014
English
15-05-2008
Committee |
E 13
|
DocumentType |
Standard Practice
|
Pages |
11
|
PublisherName |
American Society for Testing and Materials
|
Status |
Superseded
|
SupersededBy |
1.1 This practice covers requirements for the validation of empirically derived calibrations (Note 1) such as calibrations derived by Multiple Linear Regression (MLR), Principal Component Regression (PCR), Partial Least Squares (PLS), Artificial Neural Networks (ANN), or any other empirical calibration technique whereby a relationship is postulated between a set of variables measured for a given sample under test and one or more physical, chemical, quality, or membership properties applicable to that sample.
Note 1—Empirically derived calibrations are sometimes referred to as “models” or “calibrations.” In the following text, for conciseness, the term “calibration” may be used instead of the full name of the procedure.
1.2 This practice does not cover procedures for establishing said postulated relationship.
1.3 This practice serves as an overview of techniques used to verify the applicability of an empirically derived multivariate calibration to the measurement of a sample under test and to verify equivalence between the properties calculated from the empirically derived multivariate calibration and the results of an accepted reference method of measurement to within control limits established for the prespecified statistical confidence level.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
ASTM E 2898 : 2014 | Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications |
ASTM E 2475 : 2010 : R2016 | Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control |
ASTM D 7889 : 2013 | Standard Test Method for Field Determination of In-Service Fluid Properties Using IR Spectroscopy |
ASTM E 2891 : 2013 | Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications |
ASTM D 7825 : 2018 | Standard Practice for Generating a Process Stream Property Value through Application of a Process Stream Analyzer |
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