Results 1 to 10 of about 548 (98)

Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering [PDF]

Pharmaceutics, 2023
Well-characterized and scalable downstream processes for the purification of biologics are extremely demanding for delivering quality therapeutics to patients at a reasonable price.
Rony Roy, Samir Kumar, Mohammad Mohiuddin   +2 more
exaly   +6 more sources

Quality by Design: Development of the Quality Target Product Profile (QTPP) for Semisolid Topical Products [PDF]

Pharmaceutics, 2020
In recent years, the “quality by design” (QbD) approach has been used for developing pharmaceutical formulations. This is particularly important for complex dosage forms such as topical semisolid products.
Sarika Namjoshi, Michael J. Roberts, Yousuf H Mohammed   +2 more
exaly   +8 more sources

A Quintuple-Bimorph Tenfold-Chamber Piezoelectric Pump Used in Water-Cooling System of Electronic Chip

IEEE Access, 2020
To meet the dual requirement of high flow rate and high output pressure in water-cooling system of electronic chip, a quintuple-bimorph tenfold-chamber piezoelectric pump (QTPP) is presented, which owns the comprehensive advantages of parallel and serial
Mai Yu, Fuqin Deng, Zhonghua Zhang
exaly   +3 more sources

Punctal and Intracanalicular Drug Delivery Systems for Ophthalmic Use: A Narrative Review of Technologies, Clinical Outcomes, and Critical Quality Attributes [PDF]

Pharmaceutics
Background: Conventional ophthalmic eye drops have low bioavailability (80% over 4 weeks), swelling degree (30–60%), controlled burst release (
Elena O. Bakhrushina, Kseniia S. Leonova, Nikita O. Belyavsky, Vladimir I. Gegechkori, Vasily V. Belyaev, Boris B. Sysuev, Damir K. Salakhetdinov, Ivan I. Krasnyuk, Eugenia L. Atkova, Vasily D. Yartsev   +9 more
doaj   +2 more sources

Design Verification Testing for Prefilled Syringes: A Structured Best-Practice Framework [PDF]

Pharmaceutics
Background: Prefilled syringes (PFSs) are increasingly used for self- and assisted administration of high-value parenterals, yet design verification (DV) planning remains challenging due to overlapping drug, device, and combination product expectations ...
Bettine Boltres, Olga Laskina, Brett Andrejko   +2 more
doaj   +2 more sources

Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications [PDF]

Pharmaceutics
Background/Objectives: Quality by Design (QbD) has revolutionized pharmaceutical development by transitioning from reactive quality testing to proactive, science-driven methodologies.
Shiwei Yang, Xingming Hu, Jinmiao Zhu, Bin Zheng, Wenjie Bi, Xiaohong Wang, Jialing Wu, Zimeng Mi, Yifei Wu   +8 more
doaj   +2 more sources

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

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   +2 more sources

Bioactive PLA Filament with Antibacterial and Ion-Releasing Properties for Additive Manufacturing of Bone Scaffolds: QbD-Guided Development [PDF]

Pharmaceutics
Background/Objectives: The development of multifunctional biomaterials for bone regeneration remains a key challenge in additive manufacturing. Although polylactic acid (PLA) is widely used in fused deposition modeling (FDM), its limited bioactivity and ...
Anastassiya Khrustaleva, Azamat Yedrissov, Dmitriy Khrustalev, Ivan Chernykh, Aleksandr Samorodov, Saule Akhmetova, Artyom Savelyev, Marlen Kiikbayev, Polina Rusyaeva, Vladimir Kazantsev, Kristina Perepelitsyna, Sofiya Shapovalenko   +11 more
doaj   +2 more sources

A risk-based, QTPP-driven framework for semi-solid extrusion 3d printing of personalized medicines: Integrating hospital compounding and clinical trial regulation

European Journal of Pharmaceutical Sciences
Semi-solid extrusion (SSE) 3D printing enables precise, patient-specific oral medicines, yet its uptake is constrained by fragmented regulatory pathways. This study develops an applied, risk-based framework grounded in empirical data from hospital compounding and early-phase clinical trial implementation, integrating both within a unified regulatory ...
Maxime Annereau, Bernard Do, Philippe-Henri Secrétan   +2 more
exaly   +3 more sources

Quality by design- newer technique for pharmaceutical product development

Intelligent Pharmacy
Regulatory bodies are nowadays concerned with pharmaceutical drug products' safety, efficacy, and quality. Quality is the priority of all regulatory bodies, it is a high priority for the triple P factor (patient, pharmacist, and physician).
Mohsin Ali Khan, Md. Faheem Haider, Anwar Khan   +2 more
exaly   +3 more sources