Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allo...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2015/868727 |
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| author | Ramalingam Peraman Kalva Bhadraya Yiragamreddy Padmanabha Reddy |
| author_facet | Ramalingam Peraman Kalva Bhadraya Yiragamreddy Padmanabha Reddy |
| author_sort | Ramalingam Peraman |
| collection | DOAJ |
| description | Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). |
| format | Article |
| id | doaj-art-68b136a860374a2d99c1f715fc3071a4 |
| institution | Kabale University |
| issn | 1687-8760 1687-8779 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-68b136a860374a2d99c1f715fc3071a42025-02-03T05:48:08ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792015-01-01201510.1155/2015/868727868727Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust AnalyticsRamalingam Peraman0Kalva Bhadraya1Yiragamreddy Padmanabha Reddy2College of Pharmacy, Gulf Medical University, Ajman, UAESwaroop Tech Consultancy, Hyderabad, Andhra Pradesh, IndiaAnalytical Research Laboratory, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur 515721, IndiaVery recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).http://dx.doi.org/10.1155/2015/868727 |
| spellingShingle | Ramalingam Peraman Kalva Bhadraya Yiragamreddy Padmanabha Reddy Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics International Journal of Analytical Chemistry |
| title | Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics |
| title_full | Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics |
| title_fullStr | Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics |
| title_full_unstemmed | Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics |
| title_short | Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics |
| title_sort | analytical quality by design a tool for regulatory flexibility and robust analytics |
| url | http://dx.doi.org/10.1155/2015/868727 |
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