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KMID : 1142220210160020143
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.143 ~ p.149
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Logics and Case Analysis of Equivalence Testing Subject to Analytical Method Change in Quality Control of Biologics
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Eom Joon-Ho
Choi Jin-Shil
Park Ji-Won
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Abstract
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Analytical methods for quality control may be changed in development and manufacturing process of biologics. Analytical method change can result from various factors such as analytical method improvement and exchange of important component. Equivalence between current method and new method in analytical method change should verified for safety and efficacy in final products. This study aims to present proper statistical logic and cases so that developers and quality analyzers on site of biologics draw reasonable outcomes of equivalence testing. For this purpose, related papers and documents were investigated and statistical logics and cases of equivalence testing subject to analytical method change were organized. And TOST was presented as most common logic of equivalence testing in change of analytical method. This results can be useful to developer and quality analyzer on site of biologics.
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KEYWORD
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Equivalence Testing, Quality Control, Statistical Analysis, Biologics
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