Evaluation of a quality by design approach to addressing drug shortages in generic injectable pharmaceutical products [PDF]
Drug shortages, particularly generic sterile-injectable formulations, present a serious problem to manufacturers, regulators, prescribers, and patients in the United States.
Venyak, Zachary S
core
Quality-by-design in pharmaceutical development
This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually ...
Đurić, Zorica +2 more
core +1 more source
Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product. [PDF]
Pielenhofer J +12 more
europepmc +1 more source
REVIEW ON QUALITY BY DESIGN (QbD)
Atul R. Bendale +4 more
openaire +1 more source
A Review on Quality by Design (Qbd) in Pharmacutical Development
This review explains the idea of pharmaceutical Quality by Design (QbD) more clearly and talks about its main goals. QbD focuses on making sure that medicines are designed and made with high quality from the beginning. It includes several important parts.
Mayuri Ankar +3 more
openaire +1 more source
Supplementary Information Design and Optimization for One Pot Synthesis of Calcium Orotate Using a Quality by Design (QBD) Approach [PDF]
The research focuses on the design and optimization of a one-pot synthesis method for calcium orotate, utilizing a Quality by Design (QbD) approach.
Forum J. Jalundhwala, Vaishali Y. Londhe, Bharat S. Shah
core +1 more source
The advent of COVID-19 has highlighted the value of repurposing existing antiviral medications and the importance of developing efficient analytical methods to assist their quality control.
Fatma H. Ghazy +3 more
doaj +1 more source
Development of Bedaquiline-Loaded SNEDDS Using Quality by Design (QbD) Approach to Improve Biopharmaceutical Attributes for the Management of Multidrug-Resistant Tuberculosis (MDR-TB). [PDF]
Jahan RN +7 more
europepmc +1 more source
Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation. [PDF]
Harish V +11 more
europepmc +1 more source
Optimization of the Micellar-Based In Situ Gelling Systems Posaconazole with Quality by Design (QbD) Approach and Characterization by In Vitro Studies. [PDF]
Durgun ME +4 more
europepmc +1 more source

