Regulatory agencies and the pharmaceutical industry are currently focusing on the use of Quality by Design (QbD) in the creation of Pharmaceutical products. In its recommendations for the industry, the International Conference on Harmonization and the United States Food and Drug Administration (USFDA) underlined the QbD principles and applications in Pharmaceutical Development. The USFDA established a question-based review process for the chemical, manufacturing, and controls component of abbreviated new drug applications that addresses QbD qualities. When QbD principles are applied, effective product development, rapid regulatory approval, a reduced burden from extensive validation, and a considerable decrease in post-approval adjustments result. To comprehend the performance of dosage forms within design space, the major components of Quality by design—namely, the goal product quality profile, crucial quality attributes, risk assessments, design space, control strategy, product lifecycle management, and ongoing improvement—are examined. Additionally mentioned are the design of experiments, risk assessment techniques, and process analytical technologies. The significance of QbD in fostering a science-based approach in Pharmaceutical Product Development is highlighted by this review.
Yong Xiao Wang
Albany Medical College, United States
Consolato M Sergi
Universities of Alberta and Ottawa, Canada
Vladlen Slepak
University of Miami Miller School of Medicine, United States
Andreas M Papas
Antares Health Products, United States
Axel H Schonthal
University of Southern California, United States
Bernd Blobel
University of Regensburg, Germany
Gurpreet Singh
IQVIA, United Kingdom
Rassa Pegahi
UPSA, France
Tanuja Tummala
Harrisburg University of Science and Technology, United States
Natassa Pippa
University of Athens, GreeceSubmit your abstract Today
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Vladlen Slepak, University of Miami Miller School of Medicine, United States
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Bernd Blobel, University of Regensburg, Germany
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Maria Cristina Gamberini, University of Modena e Reggio Emilia, Italy
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Madhav Bhatia, University of Otago, New Zealand
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Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
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Luis Jesus Villarreal Gomez, FCITEC - Universidad Autónoma de Baja California, Mexico
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Bhupendra Gopalbhai Prajapati, Parul University, India
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Miroslav Radenkovic, University of Belgrade, Serbia