1st Edition
by Sarwar Beg (Editor), Hasnain PhD, Md Saquib (Editor)
Pharmaceutical Quality by Design: Principles and Applications discusses
the Quality by Design (QbD) concept implemented by regulatory agencies
to ensure the development of a consistent and high-quality
pharmaceutical product that safely provides the maximum therapeutic
benefit to patients. The book walks readers through the QbD framework by
covering the fundamental principles of QbD, the current regulatory
requirements, and the applications of QbD at various stages of
pharmaceutical product development, including drug substance and
excipient development, analytical development, formulation development,
dissolution testing, manufacturing, stability studies, bioequivalence
testing, risk and assessment, and clinical trials.
Contributions
from global leaders in QbD provide specific insight in its application
in a diversity of pharmaceutical products, including
nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of
illustrations, practical examples, and case studies makes this book a
useful reference guide to pharmaceutical scientists and researchers who
are engaged in the formulation of various delivery systems and the
analysis of pharmaceutical product development and drug manufacturing
process.
- Discusses vital QbD precepts and fundamental aspects
of QbD implementation in the pharma, biopharma and biotechnology
industries
- Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers
- Includes contributions from global leaders and experts from academia, industry and regulatory agencies
