Search Results - "Quality attributes"

Advanced characterization of alpha-galactosidase nanoliposomal formulations for Fabry disease treatment

Authors: Carreño Fibla, Aida

Thesis Advisors: Ventosa, Nora, Corchero Nieto, José Luis, González Mira, Elisabet

Source: TDX (Tesis Doctorals en Xarxa)

Subject Terms: Nanoliposomes, Nanoliposomas, Alfa-galactosidasa, Alpha-galactosidase, Atributs crítics de qualitat, Critical quality attributes, Atributos críticos de calidad, Ciències Experimentals

File Description: application/pdf

Access URL: http://hdl.handle.net/10803/691602

Visualizing CI’s role in software quality attribute evaluation: A Roadmap for Using Continuous Integration Environments

Authors: Yu, Liang Alégroth, Emil Chatzipetrou, Panagiota et al.

Source: Communications of the ACM. 67(6):82-90

Subject Terms: Attribute evaluation, Continuous integrations, Integration environments, Roadmap, Software quality attributes, Computer software selection and evaluation

File Description: electronic

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:bth-26367
https://doi.org/10.1145/3631519

Quality control programmes for induced pluripotent stem cell-derived medicinal products

Authors: E. V. Melnikova O. A. Rachinskaya I. S. Semenova et al.

Source: Биопрепараты: Профилактика, диагностика, лечение, Vol 25, Iss 2, Pp 127-140 (2025)

Subject Terms: somatic cell therapy medicinal product, regulatory authorities, induced pluripotent stem cells, cell reprogramming, quality attributes, Medicine, cell therapy, tissue-engineered medicinal product, quality control, TP248.13-248.65, cell bank, Biotechnology

Access URL: https://doaj.org/article/f864f78c5b834aaeb2c91f363b558287

The Aspects of Manufacturing and Quality Control of Somatic Medications Based on Mesenchymal Stem Cells

Authors: O. A. Rachinskaya E. V. Melnikova V. A. Merkulov

Source: Антибиотики и Химиотерапия, Vol 70, Iss 1-2, Pp 58-75 (2025)

Subject Terms: somatic medications, specification, quality attributes, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, quality control, mesenchymal stem/stromal cells, RC254-282

Access URL: https://doaj.org/article/89c7f18d5fe14fcc9d4d1336570f4850

Stability and bioequivalence challenges in generic drug formulation: A regulatory perspective

Authors: DuPont, Maria Elise

Source: GSC Biological and Pharmaceutical Sciences. 31:166-178

Subject Terms: Bio Equi valance (BE), CHMP (Committee For Medicinal Products For Human Use), Stability Testing, Federal Drug Administration (FDA), Prequalification of Medicines Programme (PQP), Chas (Critical Quality Attributes), Abbreviated New Drug Application (ANDA)

Application of the Quality-by-Design Approach at the Laboratory Stage of Tablet Development

Authors: M. V. Karlina V. M. Kosman M. N. Makarova et al.

Source: Регуляторные исследования и экспертиза лекарственных средств, Vol 15, Iss 2, Pp 168-178 (2025)

Subject Terms: quality target product profile, Medicine (General), R5-920, quality by design, laboratory stage, critical material parameters, dosage form, tablets, critical process parameters, critical quality attributes, production, pharmaceutical development

Access URL: https://doaj.org/article/65c3e1696d494654a8e4410181eaa6a4

Quality by Design-Guided Development of Hydrogel-Forming Microneedles for Transdermal Delivery of Enfuvirtide

Authors: Huanhuan Li Lalitkumar K. Vora Qonita Anjani et al.

Source: ACS Appl Mater Interfaces
Li, H, Vora, L K, Anjani, Q, Abraham, A M, Cong, Y, Moreno-Castellanos, N, Ballana, E, Muñoz, E R, Nevot, M & Donnelly, R F 2025, 'Quality by design-guided development of hydrogel-forming microneedles for transdermal delivery of enfuvirtide', ACS Applied Materials & Interfaces, vol. 17, no. 18, pp. 26227-26251. https://doi.org/10.1021/acsami.5c00499

Subject Terms: enfuvirtide, quality by design, design of experiment, Hydrogels, Enfuvirtide, Administration, Cutaneous, transdermal drug delivery, Drug Delivery Systems, Needles, critical process parameters, hydrogel-forming microneedles, Animals, critical quality attributes, critical material attributes

File Description: application/pdf

Access URL: https://pubmed.ncbi.nlm.nih.gov/40063825
https://pure.qub.ac.uk/en/publications/8d0099db-4627-44b9-bd13-6fbb89f6c121

When conventional approach in toxicity assays falls short for nanomedicines: a case study with nanoemulsions

Authors: Ines Nikolić Jelena Đoković Dora Mehn et al.

Source: Drug Deliv Transl Res
Drug Delivery and Translational Research

Subject Terms: Nanoemulsions, PEGylation, In vitro cytotoxicity, Critical quality attributes, Original Article, Orthogonal techniques, Nanomedicines

Access URL: https://farfar.pharmacy.bg.ac.rs/handle/123456789/5902

End-to-end dataflow engineering framework of honey manufacturing from intermediates to process by TAS1R2@AuNPs/SPCE biosensor coupled with quality transfer principle

Authors: Xiaoyan Hu Jingqi Zeng Lijuan Ma et al.

Source: Fundam Res
Fundamental Research, Vol 5, Iss 1, Pp 407-418 (2025)

Subject Terms: Q1-390, Science (General), End-to-end dataflow, Critical quality attributes, 02 engineering and technology, Honey manufacturing, Quality transfer principle, 0210 nano-technology, 01 natural sciences, Biosensor, Article, 0104 chemical sciences

Access URL: https://pubmed.ncbi.nlm.nih.gov/40166091
https://doaj.org/article/a1dc7692b2b746918f562d058a1d5460

Architecting Digital Twins

Authors: Ferko, Enxhi Bucaioni, Alessio Behnam, Moris

Source: IEEE Access. 10:50335-50350

Subject Terms: Digital twin, Systematics, Software architecture, Computer architecture, Standards, Market research, Planning, Architectural patterns, software architectures, quality attributes

File Description: print

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-58351
https://doi.org/10.1109/ACCESS.2022.3172964

Perceived Quality Attributes Importance Ranking Methodology in the Automotive Industry: A Case Study on Geometry Appearance Attributes at CEVT

Authors: Stylidis, Kostas Quattelbaum, Bastian Bergsjö, Dag et al.

Source: Procedia CIRP. 107:1559-1564

Subject Terms: Automotive industry, Product design, Sales, Attribute importance, Automotives, Case-studies, Integral part, Perceived quality, Pqair, Quality attributes, Quality evaluation, Ranking methodologies, Vehicle technology, Product development

File Description: electronic

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:hv:diva-19190
https://doi.org/10.1016/j.procir.2022.05.191

Empirical research on requirements quality: a systematic mapping study

Authors: Montgomery, Lloyd Fucci, Davide Bouraffa, Abir et al.

Source: Requirements Engineering. 27(2):183-209

Subject Terms: Empirical research, Requirements quality, Secondary study, Systematic mapping study, Mapping, Quality control, Development programmes, High quality, Meta-study, Quality attributes, Quality requirements, Requirement engineering, Requirement quality, Systematic mapping studies, Requirements engineering

File Description: electronic

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:bth-22672
https://doi.org/10.1007/s00766-021-00367-z

Impact of diverse substrate combinations and container types on strawberry quality in soilless cultivation

Authors: Sharma, Vikas Kumar Godara, Anil Kumar Malik, Arvind et al.

Source: 15(3):39-46

Quality by Design (QBD) in Pharmaceutical Development: A Review of Principles and Case Studies

Authors: Vasave, B. Lucky Bhamare, S. Mayur Bachhav, L. Rushikesh et al.

Source: 17(3):203-211

Orthogonal approach and critical quality attributes for gene and cell therapy products

Authors: Ekaterina V. Melnikova Marina A. Vodyakova Nikita S. Pokrovsky et al.

Source: Research Results in Pharmacology, Vol 11, Iss 3, Pp 87-97 (2025)

Subject Terms: orthogonal approach, quality attributes, quality control, cell therapy, gene therapy, Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://rrpharmacology.ru/index.php/journal/article/view/738; https://doaj.org/toc/2658-381X

Access URL: https://doaj.org/article/7d51b078099c4e61bac14463a976ebe7

Exploring the challenges faced by generic version of complex drugs: a scoping review

Authors: Amatha Sreedevi Elstin Anbu Raj D. Sreedhar et al.

Source: Systematic Reviews, Vol 14, Iss 1, Pp 1-19 (2025)

Subject Terms: Complex generics, Hybrid drugs, Critical quality attributes, Quality and safety, Hurdles, Medicine

File Description: electronic resource

Relation: https://doaj.org/toc/2046-4053

Access URL: https://doaj.org/article/69c4092f12574f2d91c9723b5cf2531b

Control of IgG glycosylation in CHO cell perfusion cultures by GReBA mathematical model supported by a novel targeted feed, TAFE

Authors: Zhang, Liang Schwarz, Hubert Wang, Mingliang et al.

Source: Metabolic engineering. 65:135-145

Subject Terms: Antibody, CHO cells, Feed design, Galactose, Glucose, Glycosylation, GReBA, Mannose, Mathematical modelling, Perfusion culture, Animal cell culture, Carbon, Feeding, Glycoproteins, Mammals, Polysaccharides, Rhenium compounds, Statistical methods, Attractive strategies, Chinese Hamster ovary cells, Different carbon sources, Leave-one-out cross-validation (LOOCV), Mammalian cell culture, N-linked glycosylation, Perfusion cell cultures, Quality attributes, Cells

File Description: print

Access URL: https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-290849
https://doi.org/10.1016/j.ymben.2020.11.004

ROLE OF QUALITY BY DESIGN (QBD) IN ENHANCING THE ROBUSTNESS OF SOLID ORAL DOSAGE FORMS

Authors: Dr. Deepak Shrivastava

Subject Terms: Process Analytical Technology, Solid Oral Dosage Forms, Quality by Design, Robustness, QbD, Design Space, Critical Quality Attributes

Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs

Authors: Herbst, Laura Nießing, Bastian Schmitt, Robert H.

Source: Frontiers in Bioengineering and Biotechnology. 13

Subject Terms: Quality-by-design, Bioreactor, Critical quality attributes, Mesenchymal stem cells, Critical process parameter, Standardization

Design of a Meta-Factory for Product Lines Model-Driven Software

Authors: Vidjinnangni Alphonse Ignace Azonhoumon

Source: 28th ACM International Systems and Software Product Line Conference. :6-10

Subject Terms: SPL, DSML, Product derivation, Quality attributes, Tactics

Access URL: https://researchportal.unamur.be/en/publications/d4b795da-2e52-4742-acbb-d41a56978e81
https://doi.org/10.1145/3646548.3676545