HIGH QUALITY SCIENTIFIC CONTENT,  ONLINE OPEN ACCESS,  GLOBAL SCIENTIFIC AUDIENCE,  COST EFFECTIVE, ANY ONE CAN DOWNLOAD REPRINTS 
Spreading knowledge

Google Scholar

Google Scholar

Archives

Back 

FORMULATION DEVELOPMENT APPROACHES BASED ON QUALITY BY DESIGN (QBD) AND DESIGN OF EXPERIMENT (DOE). Sumit Choudhary,Dipankar Bhadra

FORMULATION DEVELOPMENT APPROACHES BASED ON QUALITY BY DESIGN (QBD) AND DESIGN OF EXPERIMENT (DOE).

Sumit Choudhary,Dipankar Bhadra


International Journal of Natural Product Science 2012: Spl Issue 1:132.

Abstract(RBIP-132)

Today quality becomes the most integral part in a formulation development. QbD is a systematic approach for such formulation development that begins with pre-defined objectives and emphasizes product and process understanding based on sound science and quality risk management (QRM). Further DoE is a statistical tool used in QbD approach for formulation optimization, which is used for determining the relationship between different manufacturing parameters and understanding their impact on final product. DoE methods include use of Factorial, Plackett Burman design, Response surface methodologies, Taguchi method, ANOVA etc. Thus, DoE methods can provide the necessary depth of product and process understanding which will improve the quality, safety and efficacy of drug product. A systematic application of DoE facilitates the identification of critical process parameters (CPPs) and their relationship to critical quality attributes (CQAs), leading to the development of a design space. In combination with QRM and process analytical technologies (PAT), these help in maintaining good manufacturing control and consistent quality of drug products.

Keywords: DoE, QbD, PAT, ANOVA.
Attachments:
Time to create page: 0.17 seconds


Copyright © All rights reserved Science Instinct Publications sciipub.com