A concise review on method development and validation parameters

Method development is a broad term. In both quantitative and qualitative analysis developing a new method either for estimation of quantity of substance or to check the presence of the required component is a necessitate step. Validation means to establish the characteristics parameters of the metho...

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Published inGSC biological and pharmaceutical sciences Vol. 19; no. 1; pp. 66 - 77
Main Authors Shipra Thapar, Anshul Chawla, Girish Kumar Gupta
Format Journal Article
LanguageEnglish
Published 30.04.2022
Online AccessGet full text
ISSN2581-3250
2581-3250
DOI10.30574/gscbps.2022.19.1.0136

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Abstract Method development is a broad term. In both quantitative and qualitative analysis developing a new method either for estimation of quantity of substance or to check the presence of the required component is a necessitate step. Validation means to establish the characteristics parameters of the method. It also helps by revealing the limitations and their extent of the method. Both terms are essential to create and then establish for any drug component so that it can be used in any pharmaceutical industry for its benefit. Generally, the guidelines are followed as laid by ICH and USP which are followed worldwide. In this review article, some parts have been explained in reference to the subject quoted above.
AbstractList Method development is a broad term. In both quantitative and qualitative analysis developing a new method either for estimation of quantity of substance or to check the presence of the required component is a necessitate step. Validation means to establish the characteristics parameters of the method. It also helps by revealing the limitations and their extent of the method. Both terms are essential to create and then establish for any drug component so that it can be used in any pharmaceutical industry for its benefit. Generally, the guidelines are followed as laid by ICH and USP which are followed worldwide. In this review article, some parts have been explained in reference to the subject quoted above.
Author Girish Kumar Gupta
Anshul Chawla
Shipra Thapar
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