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.
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
Sergey Suchkov
The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian FederationSubmit your abstract Today
Title : Medical liver biopsy: Toward a personalized approach
Consolato M Sergi, Universities of Alberta and Ottawa, Canada
Title : Macitentan/tadalafil combination– An additional value in pharmacotherapy of pulmonary arterial hypertension
Miroslav Radenkovic, University of Belgrade, Serbia
Title : Ectopically expressed olfactory receptors as an untapped family of drug targets and discovery of agonists and antagonists of OR51E1, an understudied G protein-coupled receptor
Vladlen Slepak, University of Miami Miller School of Medicine, United States
Title : Mathematical modeling the disc diffusion test: Antibacterial activity of copper-doped SnO2
Paulo Cesar De Morais, Catholic University of Brasilia, Brazil
Title : Emerging formulation and delivery applications of Vitamin E TPGS
Andreas M Papas, Antares Health Products, United States
Title : The promise of nanotechnology in personalized & precision medicine: Drug discovery & development being partnered with nanotechnologies via the revolution at the nanoscale
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model through design-inspired biotech- & biopharma-driven applications and upgraded business marketing to secure the human healthcare and biosafety
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Design and evaluation of exo-itc: A bilayer fibrous system for controlled exosome delivery in dermatological applications
Luis Jesus Villarreal Gomez, FCITEC - Universidad Autónoma de Baja California, Mexico
Title : Antibody-proteases as translational tools of the next-step generation to be applied for biopharmacy-related and precision medical practice
Sergey Suchkov, The Russian University of Medicine and Russian Academy of Natural Science-Moscow, Russian Federation
Title : Understanding drug transport in plasma: The role of protein binding
Saad Tayyab, UCSI University, Malaysia