Quality by Design (QbD) Approach in Pharmaceutics: A Critical Review

Authors

  • Avinash Dewangan , Rajendra Kumar Sahu Author

DOI:

https://doi.org/10.48047/

Keywords:

Quality by Design (QbD), pharmaceutics, drug development, manufacturing, regulatory framework, methodologies, applications, challenges, emerging trends

Abstract

The Quality by Design (QbD) approach has emerged as a valuable tool in pharmaceutics, offering a systematic and scientific approach to product development and manufacturing. This critical review explores the key concepts, principles, and methodologies of QbD in pharmaceutics, highlighting its applications, challenges, and future directions. The review examines the historical development of QbD, its key concepts and principles, and the regulatory framework and guidelines governing its implementation.

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Published

2020-11-14

Issue

Vol. 11 No. 10 (2020): volume 11 issue 10 (2020)

Section

Articles