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Title: :  A Review on Quality by Design Approach for Analytical Method Development
PaperId: :  23090
Published in:   International Journal Of Advance Research And Innovative Ideas In Education
Publisher:   IJARIIE
e-ISSN:   2395-4396
Volume/Issue:    Volume 10 Issue 2 2024
DUI:    16.0415/IJARIIE-23090
Licence: :   IJARIIE is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Author NameAuthor Institute
Nhavale GeetaPravara Rural College Of Pharmacy
Katore VanitaPravara Rural College Of Pharmacy
Godge RPravara Rural College Of Pharmacy
Bhawar HPravara Rural College Of Pharmacy

Abstract

Pharmaceutical
Quality by Design (QbD), Design ofExperiments (DOE), Risk assessment, Analytical QbD
Quality by Design is the modern approach for quality of pharmaceuticals.Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design principles for in depth process understanding to ensure that product quality is built in by design.Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. The purpose of this paper is to discuss the pharmaceutical quality by design and the main objective of the present review article is to describe different steps involved in method development by the QbD approach for analytical method development.In a QbD approach,the impact and interactions between critical method variables are understood using a Design of Experiments approach, multivariate analysis and modeling leading to the consistent quality by drug products.The QbD approach for method development comprises various steps that include defining method intent ,performing experimental design, evaluating experimental results,selecting proper method conditions,and performing risk assessment with changing analytical parameters and conditions for evaluation.

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IJARIIE Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. "A Review on Quality by Design Approach for Analytical Method Development" International Journal Of Advance Research And Innovative Ideas In Education Volume 10 Issue 2 2024 Page 2505-2511
MLA Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. "A Review on Quality by Design Approach for Analytical Method Development." International Journal Of Advance Research And Innovative Ideas In Education 10.2(2024) : 2505-2511.
APA Nhavale Geeta, Katore Vanita, Godge R, & Bhawar H. (2024). A Review on Quality by Design Approach for Analytical Method Development. International Journal Of Advance Research And Innovative Ideas In Education, 10(2), 2505-2511.
Chicago Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. "A Review on Quality by Design Approach for Analytical Method Development." International Journal Of Advance Research And Innovative Ideas In Education 10, no. 2 (2024) : 2505-2511.
Oxford Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. 'A Review on Quality by Design Approach for Analytical Method Development', International Journal Of Advance Research And Innovative Ideas In Education, vol. 10, no. 2, 2024, p. 2505-2511. Available from IJARIIE, http://ijariie.com/AdminUploadPdf/A_Review_on_Quality_by_Design_Approach_for_Analytical_Method_Development_ijariie23090.pdf (Accessed : ).
Harvard Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. (2024) 'A Review on Quality by Design Approach for Analytical Method Development', International Journal Of Advance Research And Innovative Ideas In Education, 10(2), pp. 2505-2511IJARIIE [Online]. Available at: http://ijariie.com/AdminUploadPdf/A_Review_on_Quality_by_Design_Approach_for_Analytical_Method_Development_ijariie23090.pdf (Accessed : )
IEEE Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H, "A Review on Quality by Design Approach for Analytical Method Development," International Journal Of Advance Research And Innovative Ideas In Education, vol. 10, no. 2, pp. 2505-2511, Mar-App 2024. [Online]. Available: http://ijariie.com/AdminUploadPdf/A_Review_on_Quality_by_Design_Approach_for_Analytical_Method_Development_ijariie23090.pdf [Accessed : ].
Turabian Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. "A Review on Quality by Design Approach for Analytical Method Development." International Journal Of Advance Research And Innovative Ideas In Education [Online]. volume 10 number 2 ().
Vancouver Nhavale Geeta, Katore Vanita, Godge R, and Bhawar H. A Review on Quality by Design Approach for Analytical Method Development. International Journal Of Advance Research And Innovative Ideas In Education [Internet]. 2024 [Cited : ]; 10(2) : 2505-2511. Available from: http://ijariie.com/AdminUploadPdf/A_Review_on_Quality_by_Design_Approach_for_Analytical_Method_Development_ijariie23090.pdf
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