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Database Design for Quality [PDF]

, 1996
The approach employed to define a formal design methodology fot the development of easy to use, flexible, efficient and correct database systems is described.
Castelli D, Locuratolo E
openaire   +3 more sources

Understanding Pharmaceutical Quality by Design [PDF]

, 2016
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of ...
Amidon, Gregory, Hoag, Stephen W., Khan, Mansoor A., Polli, James, Raju, Gokaraju K, Woodcock, Janet, Yu, Lawrence X.   +6 more
core   +1 more source

Quality and safety by design [PDF]

Quality in Health Care, 2006
Rather than continuing to try to measure the width and depths of the quality chasm, a legitimate question is how does one actually begin to close the quality chasm? One way to think about the problem is as a design challenge rather than as a quality improvement challenge.
openaire   +2 more sources

Quality by Design Approach for Development and Characterization of Granisetron Hydrochloride-Loaded Orodispersible Films

Pharmaceutical Fronts, 2023
Granisetron hydrochloride can be used to prevent and treat nausea and vomiting induced by chemotherapy. Its prolonged half-life and reduced dose requirement improve patient acceptance. However, patients undergoing chemotherapy often suffer from dysphagia
Ming-Yan Li, Bing Wang, Jun-Qi Zhang, Liu-Liu Yang, Jun-Tao He, Fang Chen   +5 more
doaj   +1 more source

HPLC method development for fampridine using Analytical Quality by Design approach

Acta Pharmaceutica, 2020
Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends.
Kovács Béla, Boda Francisc, Fülöp Ibolya, Székely-Szentmiklósi István, Kelemen Éva Katalin, Kovács-Deák Boglárka, Székely-Szentmiklósi Blanka   +6 more
doaj   +1 more source

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

BMC Chemistry, 2023
A simple, selective, and sensitive RP-HPLC method was proposed for the simultaneous determination of two co-administered antidiabetic drugs (omarigliptin and metformin) with an anti-hyperlipidemic drug (ezetimibe) in a medicinally-recommended ratio of 2 ...
Galal Magdy, Amira A. Al-enna, Fathalla Belal, Ramadan A. El-Domany, Ahmed M. Abdel-Megied   +4 more
doaj   +1 more source

Formulation Approaches for Improving the Dissolution Behavior and Bioavailability of Tolvaptan Using SMEDDS

Pharmaceutics, 2022
Tolvaptan, a selective vasopressin receptor antagonist, is a Class IV agent of Biopharmaceutical Classification System (BCS). To improve bioavailability after oral administration, the new tolvaptan-loaded self-microemulsifying drug delivery system ...
Jong-Hwa Lee, Gye-Won Lee
doaj   +1 more source

Development of a robust and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method using analytical quality by design principles for the accurate determination of esculin in its bulk form

Future Journal of Pharmaceutical Sciences, 2023
Background Analytical quality by design is a proactive, holistic, and data-driven approach to quality that emphasizes risk assessment and management. This can lead to more robust and reliable methods than traditional approaches.
Sarvesh Patil, Anjana Adhyapak, Priya Shetti, Rohan Gurao   +3 more
doaj   +1 more source

Quality by Design Approach Using Multiple Linear and Logistic Regression Modeling Enables Microemulsion Scale Up

Molecules, 2019
The development of pharmaceutical nanoformulations has accelerated over the past decade. However, the nano-sized drug carriers continue to meet substantial regulatory and clinical translation challenges.
Michele Herneisey, Eric Lambert, Allison Kachel, Emma Shychuck, James K. Drennen, Jelena M. Janjic   +5 more
doaj   +1 more source

An evaluation tool for design quality: PFI sheltered housing [PDF]

, 2013
The complex procurement process entailed by the private finance initiative (PFI) means that clients need new capacities to manage their relationships with bidders and to assess project proposals if the desired level of design quality is to be achieved ...
Giddings, Bob, Jensen, Phil, Jones, Paul, Sharma, Monika   +3 more
core   +2 more sources