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  • ASTM
    E2891-13 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
    Edition: 2013
    $103.58
    Unlimited Users per year

Description of ASTM-E2891 2013

ASTM E2891-13

Historical Standard: Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications




ASTM E2891

Scope

1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products.

1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:

1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status),

1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers),

1.2.3 Considerations on the different types of data analysis and model validation,

1.2.4 Qualified and competent personnel, and

1.2.5 Life-cycle management of MVDA.

1.3 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.


Keywords

chemometrics; chemometric model; data analysis method validation; data model; exploratory data analysis; model building; model validation; multivariate data analysis; outliers; predictive data analysis; process analytical technology


ICS Code

ICS Number Code 11.120.01 (Pharmaceutics in general)


DOI: 10.1520/E2891-13

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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