Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Joint Authors
Peraman, Ramalingam
Bhadraya, Kalva
Padmanabha Reddy, Yiragamreddy
Source
International Journal of Analytical Chemistry
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-02-02
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
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).
American Psychological Association (APA)
Peraman, Ramalingam& Bhadraya, Kalva& Padmanabha Reddy, Yiragamreddy. 2015. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. International Journal of Analytical Chemistry،Vol. 2015, no. 2015, pp.1-9.
https://search.emarefa.net/detail/BIM-1064452
Modern Language Association (MLA)
Peraman, Ramalingam…[et al.]. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. International Journal of Analytical Chemistry No. 2015 (2015), pp.1-9.
https://search.emarefa.net/detail/BIM-1064452
American Medical Association (AMA)
Peraman, Ramalingam& Bhadraya, Kalva& Padmanabha Reddy, Yiragamreddy. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. International Journal of Analytical Chemistry. 2015. Vol. 2015, no. 2015, pp.1-9.
https://search.emarefa.net/detail/BIM-1064452
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1064452