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ASTM E 2617 : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Practice for Validation of Empirically Derived Multivariate Calibrations

Available format(s)

Hardcopy , PDF

Superseded date

18-12-2024

Superseded by

ASTM E 2617 : 2017

Language(s)

English

Published date

01-03-2010

€74.48
Excluding VAT

Committee
E 13
DocumentType
Standard Practice
Pages
11
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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

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