ASTM WK36058

    Work Item: ASTM WK36058 - New Guide for Multivariate data analysis related to pharmaceutical development and manufacturing

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    Developed by Subcommittee: E55.01 | Committee E55 | Contact Staff Manager



    1. Scope

    1.1 This standard is intended for the application of multivariate data analysis to pharmaceutical development and manufacturing. This guide describes the data analysis concepts and provides general guidelines for each step of the lifecycle of a data analysis method, from preparation to maintenance. This guide is written in a general form for the majority of multivariate data analyses. Necessary standard guides or practices for specific data analysis topics will be established under the jurisdiction of ASTM Committee E55. 1.2 In pharmaceutical development and manufacturing, a multivariate data analysis (MVDA) usually has two phases. The first phase is to establish and validate a chemometric model, and the second phase is to use the chemometric model to predict the outcome of subsequent incoming data. The term multivariate relates to the data consisting of multiple variables collected from materials and processes, and MVDA is used to extract the information in the multivariate data.


    Keywords

    Multivariate data analysis; chemometrics; Chemometric model; Data model; Predictive:data analysis; Model space; Data analysis method validation; Model validation; Process:analytical technology.

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    01-18-2012

    Technical Contact:
    Chun Cai

    Item:
    001

    Ballot:
    E55 (13-01)

    Status:
    Ballot Item Approved as E2891-2013 and Pending Publication