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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-11-01
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| Series: | Plants |
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| Online Access: | https://www.mdpi.com/2223-7747/11/21/2960 |
| _version_ | 1797466785615708160 |
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| author | Geonha Park Min Kyoung Kim Seung Hyeon Go Minsik Choi Young Pyo Jang |
| author_facet | Geonha Park Min Kyoung Kim Seung Hyeon Go Minsik Choi Young Pyo Jang |
| author_sort | Geonha Park |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T18:44:37Z |
| format | Article |
| id | doaj.art-f70030e0eb5e4ba5b1916b67adf49cbe |
| institution | Directory Open Access Journal |
| issn | 2223-7747 |
| language | English |
| last_indexed | 2024-03-09T18:44:37Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Plants |
| spelling | doaj.art-f70030e0eb5e4ba5b1916b67adf49cbe2023-11-24T06:25:54ZengMDPI AGPlants2223-77472022-11-011121296010.3390/plants11212960Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal PlantsGeonha Park0Min Kyoung Kim1Seung Hyeon Go2Minsik Choi3Young Pyo Jang4Department of Life and Nanopharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul 02447, KoreaDivision of Pharmacognosy, College of Pharmacy, Kyung Hee University, Seoul 02447, KoreaDepartment of Biomedical and Pharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul 02447, KoreaDepartment of Biomedical and Pharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul 02447, KoreaDepartment of Life and Nanopharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul 02447, KoreaScientific 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.https://www.mdpi.com/2223-7747/11/21/2960analytical quality by design (AQbD)medicinal plantsnatural productsanalytical toolslifecycle managementmethod operable design region (MODR) |
| spellingShingle | Geonha Park Min Kyoung Kim Seung Hyeon Go Minsik Choi Young Pyo Jang Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants Plants analytical quality by design (AQbD) medicinal plants natural products analytical tools lifecycle management method operable design region (MODR) |
| 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 | analytical quality by design (AQbD) medicinal plants natural products analytical tools lifecycle management method operable design region (MODR) |
| url | https://www.mdpi.com/2223-7747/11/21/2960 |
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