المؤلفون: Thayana A. Cruz, Nicholas R. Larson, Yangjie Wei, Natalia Subelzu, Yaqi Wu, Christian Schöneich, Leda R. Castilho, Charles Russell Middaugh

المصدر: Biologics, Vol 4, Iss 3, Pp 294-313 (2024)

مصطلحات موضوعية: anti-PCSK9 monoclonal antibody, evolocumab, Repatha, mAb characterization, critical quality attributes (CQAs), Biology (General), QH301-705.5

وصف الملف: electronic resource

Relation: https://www.mdpi.com/2673-8449/4/3/19; https://doaj.org/toc/2673-8449

URL الوصول: https://doaj.org/article/4ce9af17cf744b2d9eec9bbc902b6693

المؤلفون: Additiya Paramanya, Abeeb Oyesiji Abiodun, Mohammad Shamsul Ola, Ahmad Ali

المصدر: Arabian Journal of Chemistry, Vol 17, Iss 3, Pp 105653- (2024)

مصطلحات موضوعية: Antioxidant potential, Critical Quality Attributes (CQAs), Phycocyanin, Quality by Design (QbD) approach, Target Product Profiles (TPPs), Chemistry, QD1-999

وصف الملف: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S1878535224000558; https://doaj.org/toc/1878-5352

URL الوصول: https://doaj.org/article/1df2e36fb0ae431b85a7afbc86ba1632

المؤلفون: Pratik B. Aru, Mayur S. Gulhane, Vinayak A. Katekar, Swati P. Deshmukh

المصدر: GSC Biological and Pharmaceutical Sciences, 26(1), 328–340, (2024-01-30)

مصطلحات موضوعية: Quality by Design (QBD) Pharmaceutical Development, International Conference on Harmonization (ICH), Risk Management, Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Design Space, Real-time Release Testing (RTRT), Regulatory Compliance, Continuous Improvement, Empirical Methods, Predictability, Consistency, Case Studies, Industry 4.0, Advanced Technologies, Global Harmonization, Paradigm Shift, Patient Safety

Relation: https://zenodo.org/communities/gscbps; https://doi.org/10.5281/zenodo.10969652; https://doi.org/10.5281/zenodo.10969653; oai:zenodo.org:10969653; https://doi.org/10.30574/gscbps.2024.26.1.0019

الاتاحة: https://doi.org/10.5281/zenodo.10969653
https://doi.org/10.30574/gscbps.2024.26.1.0019

المؤلفون: Li Ya, Li Zirui, Guo Zhihua

المصدر: Digital Chinese Medicine, Vol 5, Iss 2, Pp 189-198 (2022)

مصطلحات موضوعية: Chuantieling (CTL), Quality by design (QbD), Box-Behnken design (BBD), Critical quality attributes (CQAs), Critical process parameters (CPPs), Mahuang (Ephedrae Herba), Medicine, Other systems of medicine, RZ201-999

وصف الملف: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2589377722000350; https://doaj.org/toc/2589-3777

URL الوصول: https://doaj.org/article/433d87cabdb5451fb1971a5fce8f4e68

المؤلفون: Mingyan Cao, G. Patrick Hussmann, Yeqing Tao, Ellen O’Connor, Conner Parthemore, Diana Zhang-Hulsey, Dengfeng Liu, Yang Jiao, Niluka de Mel, Meagan Prophet, Samuel Korman, Jaytee Sonawane, Christina Grigoriadou, Yue Huang, Scott Umlauf, Xiaoyu Chen

المصدر: Antibodies, Vol 12, Iss 4, p 68 (2023)

مصطلحات موضوعية: deamidation, post-translational modification (PTM), antibody drug conjugate (ADC), critical quality attributes (CQAs), biological activity, Immunologic diseases. Allergy, RC581-607

Relation: https://www.mdpi.com/2073-4468/12/4/68; https://doaj.org/toc/2073-4468; https://doaj.org/article/4a1c6cf978184bb1870f19d9d0c1a91e

الاتاحة: https://doi.org/10.3390/antib12040068
https://doaj.org/article/4a1c6cf978184bb1870f19d9d0c1a91e

المؤلفون: Anurag S. Rathore, C. Mark Smales, Andras Guttman

المصدر: Frontiers in Bioengineering and Biotechnology, Vol 10 (2022)

مصطلحات موضوعية: biotherapeutics, analytical characterisation, biosimilarity assessment, critical quality attributes (CQAs), post translational modifications (PTMs), virus like particles (VLPs), Biotechnology, TP248.13-248.65

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fbioe.2022.993262/full; https://doaj.org/toc/2296-4185

URL الوصول: https://doaj.org/article/5fe0d1af7759426b87c0785f4dd93616

المؤلفون: ABDELLATIF, MENNA M., ELTABEEB, MOAZ A., EL-NABARAWI, MOHAMED A., H. TEAIMA, MAHMOUD

المصدر: International Journal of Applied Pharmaceutics; Vol 14, Issue 4 (Jul-Aug), 2022; 48-54 ; 0975-7058

مصطلحات موضوعية: Vaginal drug delivery, Spermicides, Critical quality attributes (CQAs), High throughput production

وصف الملف: application/pdf; text/html

Relation: https://innovareacademics.in/journals/index.php/ijap/article/view/44925/26611; https://innovareacademics.in/journals/index.php/ijap/article/view/44925/26685; https://innovareacademics.in/journals/index.php/ijap/article/view/44925

الاتاحة: https://innovareacademics.in/journals/index.php/ijap/article/view/44925

المؤلفون: Maryam Dabbaghi, Sarika Namjoshi, Bhavesh Panchal, Jeffrey E. Grice, Sangeeta Prakash, Michael Stephen Roberts, Yousuf Mohammed

المصدر: Pharmaceutics; Volume 13; Issue 9; Pages: 1351

مصطلحات موضوعية: topical semisolid products, rheology, viscoelastic properties, deformation characteristics, power-law functions, critical quality attributes (CQAs)

وصف الملف: application/pdf

Relation: Drug Delivery and Controlled Release; https://dx.doi.org/10.3390/pharmaceutics13091351

الاتاحة: https://doi.org/10.3390/pharmaceutics13091351

المؤلفون: Wee Chin Wong, Ewan Chee, Jiali Li, Xiaonan Wang

المصدر: Mathematics; Volume 6; Issue 11; Pages: 242

مصطلحات موضوعية: pharmaceuticals, critical quality attributes (CQAs), recurrent neural networks, model predictive control (MPC), system identification

وصف الملف: application/pdf

Relation: https://dx.doi.org/10.3390/math6110242

الاتاحة: https://doi.org/10.3390/math6110242

المؤلفون: Lan Zhang, Shirui Mao

المصدر: Asian Journal of Pharmaceutical Sciences, Vol 11, Iss 1, Pp 144-145 (2016)

مصطلحات موضوعية: Quality by Design (QbD), Critical quality attributes (CQAs), Design of experiment (DoE), Process analytical technology (PAT), Therapeutics. Pharmacology, RM1-950

Relation: http://www.sciencedirect.com/science/article/pii/S1818087615002470; https://doaj.org/toc/1818-0876; https://doaj.org/article/f4e08bd053b24bc9a3f6238afb74e780

الاتاحة: https://doi.org/10.1016/j.ajps.2015.11.084
https://doaj.org/article/f4e08bd053b24bc9a3f6238afb74e780

المؤلفون: Henry Shion, Jing Fang, Kenji HIROSE, Min Du, Nilini Ranbaduge, Scott Berger, Weibin Chen, Ying Q. Yu, 廣瀬 賢治

المصدر: Abstracts for Annual Meeting of Japanese Proteomics Society. 2018, :290

المؤلفون: Talavera, Pere

المصدر: Revista de la Societat Catalana de Química; Núm. 20 (2021); 75-85 ; Revista de la Societat Catalana de Química; No. 20 (2021); 75-85 ; 2013-9853 ; 1576-8961

مصطلحات موضوعية: Disseny d’experiments (DoE), qualitat pel disseny (QbD), atributs crítics de qualitat (CQA), rangs acceptables del procés (PAR), espai de disseny, avaluació del risc, Design of experiments (DoE), quality by design (QbD), critical quality attributes (CQAs), process acceptable ranges (PAR), design space, risk assessment

وصف الملف: application/pdf

Relation: https://revistes.iec.cat/index.php/RSCQ/article/view/149543/147207; https://revistes.iec.cat/index.php/RSCQ/article/view/149543

الاتاحة: https://revistes.iec.cat/index.php/RSCQ/article/view/149543

المؤلفون: Michael S. Roberts, Sarika Namjoshi, Yousuf H. Mohammed, Sangeeta Prakash, Maryam Dabbaghi, Jeffrey E. Grice, Bhavesh Panchal

المساهمون: Dabbaghi, Maryam, Namjoshi, Sarika, Panchal, Bhavesh, Grice, Jeffrey E., Prakash, Sangeeta, Roberts, Michael Stephen, Mohammed, Yousuf

المصدر: Pharmaceutics, Vol 13, Iss 1351, p 1351 (2021)
Pharmaceutics
Volume 13
Issue 9

مصطلحات موضوعية: Materials science, topical semisolid products, deformation characteristics, Pharmaceutical Science, viscoelastic properties, Dynamic mechanical analysis, Viscoelasticity, Article, Shear (sheet metal), RS1-441, Viscosity, Brittleness, Pharmacy and materia medica, Rheology, Dynamic modulus, rheology, critical quality attributes (CQAs), Deformation (engineering), Composite material, power-law functions

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d567f92ca2c421dc0db8632c6a23a8e
https://hdl.handle.net/11541.2/25520

المؤلفون: Liu, I-Fen, Jiang, Ho-Lung, Chi, Wei-Kuang, Yang, Ching-Jen, Hsu, Shih-Lung, Hsu, Ming-Yen

المصدر: Integrated Continuous Biomanufacturing IV

مصطلحات موضوعية: Perfusion cultivation, Periodic counter-current (PCC) chromatography, Critical quality attributes (CQAs), Charge heterogeneity, Engineering

Relation: https://dc.engconfintl.org/biomanufact_iv/34

الاتاحة: https://dc.engconfintl.org/biomanufact_iv/34

المؤلفون: Paradkar, Anant, Aksu, Buket, de Matas, Marcel, Ozer, Ozgen, Guneri, Tamer, York, Peter

مصطلحات موضوعية: Artificial neural networks (ANNs), Quality by design (QbD), Critical quality attributes (CQAs), optimization, ramipril, wet granulation

Relation: Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı; Pharmaceutical Development and Technology; https://hdl.handle.net/11454/47878; https://doi.org/10.3109/10837450.2012.705294; 18; 236; 245

الاتاحة: https://hdl.handle.net/11454/47878
https://doi.org/10.3109/10837450.2012.705294

Additional Titles: Design space study of a chemical reaction with design of experiments

المؤلفون: Talavera, Pere

المصدر: Revista de la Societat Catalana de Química; Núm. 20 (2021); 75-85; Revista de la Societat Catalana de Química; No. 20 (2021); 75-85; Revista de la Societat Catalana de Química; Núm. 20 (2021); 75-85; 2013-9853; 1576-8961

مصطلحات الفهرس: Disseny d’experiments (DoE), qualitat pel disseny (QbD), atributs crítics de qualitat (CQA), rangs acceptables del procés (PAR), espai de disseny, avaluació del risc., Design of experiments (DoE), quality by design (QbD), critical quality attributes (CQAs), process acceptable ranges (PAR), design space, risk assessment., info:eu-repo/semantics/article, info:eu-repo/semantics/publishedVersion

URL: https://revistes.iec.cat/index.php/RSCQ/article/view/149543
https://revistes.iec.cat/index.php/RSCQ/article/view/149543/147207
https://revistes.iec.cat/index.php/RSCQ/article/view/149543/147207