NDLI: An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design

Content Provider	Springer Nature Link
Author	Hallow, Daniel M. Mudryk, Boguslaw M. Braem, Alan D. Tabora, Jose E. Lyngberg, Olav K. Bergum, James S. Rossa, Lucius T. Tummala, Srinivas
Copyright Year	2010
Abstract	In this case study, we present an approach for employing modeling to help define the design space for a reaction with potential to generate an impurity that could impact the quality of an API. Our approach broadly consisted of (1) evaluating the reaction parameters that can affect the critical impurity level to develop appropriate assumptions for a mechanistic model, (2) developing and evaluating a mechanistic model to predict the formation of the critical impurity, (3) defining a design space based on the model output to reduce in practice the acceptable parameter space to a practical number of parameters, and (4) verifying the design space through experimental testing. This work resulted in a verified design space that can be practically employed and includes wide parameters ranges for manufacturing flexibility.
Starting Page	193
Ending Page	203
Page Count	11
File Format	PDF
ISSN	18725120
Journal	Journal of Pharmaceutical Innovation
Volume Number	5
Issue Number	4
e-ISSN	19398042
Language	English
Publisher	Springer US
Publisher Date	2010-11-19
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Quality by Design Design space Mechanistic modeling Empirical modeling Verification Biochemical Engineering Biotechnology Industrial and Production Engineering Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Drug Discovery Pharmaceutical Science

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
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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