Results 91 to 100 of about 62,558,702 (211)

AQbD-novel strategy for analytical methods

Future Journal of Pharmaceutical Sciences
Background Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (
Amruta Bairagi, Rutuja Kothrukar, Hemant Chikhale, Sreya Kosanam, Laxmikant Borse   +4 more
doaj   +1 more source

Design of Experiments Leads to Scalable Analgesic Near-Infrared Fluorescent Coconut Nanoemulsions

Pharmaceutics
Background: Pain is a complex phenomenon characterized by unpleasant experiences with profound heterogeneity influenced by biological, psychological, and social factors. According to the National Health Interview Survey, 50.2 million U.S.
Amit Chandra Das, Gayathri Aparnasai Reddy, Shekh Md. Newaj, Smith Patel, Riddhi Vichare, Lu Liu, Jelena M. Janjic   +6 more
doaj   +1 more source

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

International Journal of Analytical Chemistry, 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman, Kalva Bhadraya, Yiragamreddy Padmanabha Reddy   +2 more
doaj   +1 more source

QbD not QED [PDF]

The misapplication of QbD for purposes for which it was not intended for is unwise andlikely to be counterproductive. It would be a shame if, by virtue of such misapplication, the QbD paradigm were to be maligned or abandoned, because there is no denying
Shireesh Apte
core   +1 more source

Protocol for applying an enhanced quality-by-design program across the translational science spectrum

Journal of Clinical and Translational Science
The quality by design (QbD) framework holds promise for improving success rates for completion of clinical studies, which often fail to complete on time.
Allison Zumberge Orechwa, Leslie Aguilar, Megan Castiel, Cathelin Huang, Jeanne Dzekov, Nicole M.G. Maccalla, Wendy Mack, Zoe Mele, Kaelyn Moses, Cecilia Patino-Sutton, Saira Shah, Amytis Towfighi, Thomas Buchanan   +12 more
doaj   +1 more source

REVIEW ARTICLE: QUALITY BY DESIGN (QbD)

, 2018
There is massive competition worldwide and growing impact of Information technology, the pharmaceutical industry needs to improve its performance. Newer technologies need to be implemented that can effectively reduce cost of production and at the same time improves product quality and regulatory compliance.
openaire   +2 more sources

Key information related to quality by design (QbD) applications in analytical methods development

, 2020
In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development.
Babos, Diego Victor, Gamela, Raimundo Rafael, Garcia, José Augusto, Guedes, Wesley Nascimento [UNESP], Araújo, Alisson Silva, Machado, Raquel Cardoso, Pereira-Filho, Edenir Rodrigues, Castro, Jeyne Pricylla, Costa, Vinícius Câmara, Pereira, Fabíola Manhas Verbi [UNESP], Andrade, Daniel Fernandes, Sperança, Marco Aurelio [UNESP]   +11 more
core   +1 more source

Quality by Design and In Silico Approach in SNEDDS Development: A Comprehensive Formulation Framework

Pharmaceutics
Background/Objectives: The Self-Nanoemulsifying Drug Delivery System (SNEDDS) has been widely applied in oral drug delivery, particularly for poorly water-soluble compounds.
Sani Ega Priani, Taufik Muhammad Fakih, Gofarana Wilar, Anis Yohana Chaerunisaa, Iyan Sopyan   +4 more
doaj   +1 more source

Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine [PDF]

Distributed and point-of-care (POC) manufacturing facilities enable an agile pharmaceutical production paradigm that can respond to localized needs, providing personalized and precision medicine.
William , Feeney, Johnny, Ho, John Greg, Gillen, Thomas P, Forbes   +3 more
core   +2 more sources

HOLISTIC APPLICATION OF QUALITY BY DESIGN (QbD) FOR PHARMA PRODUCT DEVELOPMENT EXCELLENCE AND REGULATORY COMPLIANCE [PDF]

The realm of optimizing the drug formulations has gained significant momentum towards more systematic approach of “Quality by Design (QbD)” based strategies employing “Design of Experiments (DoE)” from the erstwhile traditional short-gun approach of ...
Jain, Atul, Singh, Bhupinder, Sharma, Gajanand, Beg, Sarwar, Negi, Poonam   +4 more
core   +1 more source