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Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few year...

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Autores principales: Park, Geonha, Kim, Min Kyoung, Go, Seung Hyeon, Choi, Minsik, Jang, Young Pyo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9653622/
https://www.ncbi.nlm.nih.gov/pubmed/36365413
http://dx.doi.org/10.3390/plants11212960
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author Park, Geonha
Kim, Min Kyoung
Go, Seung Hyeon
Choi, Minsik
Jang, Young Pyo
author_facet Park, Geonha
Kim, Min Kyoung
Go, Seung Hyeon
Choi, Minsik
Jang, Young Pyo
author_sort Park, Geonha
collection PubMed
description Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method operable design region (MODR), and lowers the out-of-specification (OOS) results. However, it is difficult to follow all the AQbD workflow steps in the field of medicinal plants analysis, such as defining the analytical target profiles (ATPs), identifying critical analytical procedure parameters (CAPPs), among others, because the complexity of chemical and biological properties in medicinal plants acts as a barrier. In this review, various applications of AQbD to medicinal plant analytical procedures are discussed. Unlike the analysis of a single compound, medicinal plant analysis is characterized by analyzing multiple components contained in biological materials, so it will be summarized by focusing on the following points: Analytical methods showing correlations within analysis parameters for the specific medicinal plant analysis, plant raw material diversity, one or more analysis targets defined for multiple phytochemicals, key analysis attributes, and analysis control strategies. In addition, the opportunities available through the use of design-based quality management techniques and the challenges that coexist are also discussed.
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spelling pubmed-96536222022-11-15 Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants Park, Geonha Kim, Min Kyoung Go, Seung Hyeon Choi, Minsik Jang, Young Pyo Plants (Basel) Review Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method operable design region (MODR), and lowers the out-of-specification (OOS) results. However, it is difficult to follow all the AQbD workflow steps in the field of medicinal plants analysis, such as defining the analytical target profiles (ATPs), identifying critical analytical procedure parameters (CAPPs), among others, because the complexity of chemical and biological properties in medicinal plants acts as a barrier. In this review, various applications of AQbD to medicinal plant analytical procedures are discussed. Unlike the analysis of a single compound, medicinal plant analysis is characterized by analyzing multiple components contained in biological materials, so it will be summarized by focusing on the following points: Analytical methods showing correlations within analysis parameters for the specific medicinal plant analysis, plant raw material diversity, one or more analysis targets defined for multiple phytochemicals, key analysis attributes, and analysis control strategies. In addition, the opportunities available through the use of design-based quality management techniques and the challenges that coexist are also discussed. MDPI 2022-11-02 /pmc/articles/PMC9653622/ /pubmed/36365413 http://dx.doi.org/10.3390/plants11212960 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Park, Geonha
Kim, Min Kyoung
Go, Seung Hyeon
Choi, Minsik
Jang, Young Pyo
Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title_full Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title_fullStr Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title_full_unstemmed Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title_short Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants
title_sort analytical quality by design (aqbd) approach to the development of analytical procedures for medicinal plants
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9653622/
https://www.ncbi.nlm.nih.gov/pubmed/36365413
http://dx.doi.org/10.3390/plants11212960
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