NDLI: Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

Content Provider	Springer Nature Link
Author	Apostol, Izydor Kelner, Drew Jiang, Xinzhao Grace Huang, Gang Wypych, Jette Zhang, Xin Gastwirt, Jessica Chen, Kenneth Fodor, Szilan Hapuarachchi, Suminda Meriage, Dave Ye, Frank Poppe, Leszek Szpankowski, Wojciech
Copyright Year	2012
Abstract	To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry.We have conducted a comprehensive survey of purity methods, and show that all performance characteristics fall within narrow measurement ranges. This observation was used to develop a model called Uncertainty Based on Current Information (UBCI), which expresses these performance characteristics as a function of the signal and noise levels, hardware specifications, and software settings.We applied the UCBI model to assess the uncertainty of purity measurements, and compared the results to those from conventional qualification. We demonstrated that the UBCI model is suitable to dynamically assess method performance characteristics, based on information extracted from individual chromatograms.The model provides an opportunity for streamlining qualification and validation studies by implementing a “live validation” of test results utilizing UBCI as a concurrent assessment of measurement uncertainty. Therefore, UBCI can potentially mitigate the challenges associated with laborious conventional method validation and facilitates the introduction of more advanced analytical technologies during the method lifecycle.
Starting Page	3404
Ending Page	3419
Page Count	16
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	29
Issue Number	12
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2012-08-15
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Medical Law Biochemistry Pharmacology/Toxicology Pharmacy Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

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