Keywords: ویژگی کیفی بحرانی; Dynamic light scattering; Iron sucrose; Physicochemical characterization; Size distribution; Critical quality attribute;
مقالات ISI ویژگی کیفی بحرانی (ترجمه نشده)
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Keywords: ویژگی کیفی بحرانی; Industry 4.0; In silico; Computer model; Digital twin; Tissue engineering; ATMP; Advanced Therapeutic Medicinal Product; ASME; American Society of Mechanical Engineers; CAD-CAM; Computer Aided Design - Computer Aided Manufacturing; cBiT; compendium for
Keywords: ویژگی کیفی بحرانی; API; active pharmaceutical ingredient; CP; centerpoint; CQA; critical quality attribute; DOE; design of experiments; MBPH; main-compression bottom punch height; MCC; microcrystalline cellulose; MCD; main-compression displacement; MCF; main compression for
Keywords: ویژگی کیفی بحرانی; protein formulation; multivariate analysis; biotechnology; stability; excipients; formulation; quality by design; protein excipient interactions; pharmaceutical sciences; biopharmaceuticals characterization; L-Histidine (PubChem CID: 6274); L-Histidine hy
Keywords: ویژگی کیفی بحرانی; 2D-LC; Two Dimensional Liquid Chromatography; ADC; Antibody Drug Conjugate; AEX; Anion Exchange Chromatography; BEH; Bridged Ethylene Hybrid (hybrid silica); BSA; Bovine Serum Albumin; BsAb; Bispecific Antibody; CQA; Critical Quality Attribute; EMA; Europ
Keywords: ویژگی کیفی بحرانی; Recombinant therapeutics; Aggregation; Host cell proteins; Glycosylation; Regulation; Biopharmaceuticals; 2D-PAGE; Two-dimensional polyacrylamide gel electrophoresis; ADCC; antibody-dependent cell-mediated cytotoxicity; AUC/SV-AUC; (Sedimentation velocity
Keywords: ویژگی کیفی بحرانی; CCCD; circumscribed central composite design; CQA; critical quality attribute; DOE; design of experiments; QbD; quality-by-design; 3-Fluid nozzle; Design of experiments; Dissolution rate; Lipophilic drug; Poor water solubility; Solid dispersion; Spray dry
Keywords: ویژگی کیفی بحرانی; BB; bilobalide; CE; collision energy; CPP; critical process parameter; CQA; critical quality attribute; CXP; collision cell exit potential; DMSO; dimethylsulfoxide; DP; declustering potential; EP; injection voltage; ESIâ; negative ionization mode; FMEA;
Keywords: ویژگی کیفی بحرانی; Asp-N; endoproteinase AspN; BLA; biologics license application; CDR; complementarity determining region; CFR; Code of Federal Regulations; CGF; carboxyl group footprinting; cGMP; current good manufacturing practice; CHO; Chinese hamster ovary; CID; collis
Keywords: ویژگی کیفی بحرانی; robustness; quality by design; biopharmaceutical; drug product; formulation; manufacturing process; design space; BLA; biological license application; BPDG-FPS; Biophorum Development Group-Formulation Point Share; CQA; critical quality attribute; CPP; c
Design of a strong cation exchange methodology for the evaluation of charge heterogeneity in glatiramer acetate
Keywords: ویژگی کیفی بحرانی; % RTR; Retention Time Ratio Percent; ATP; Analytical Target Profile; CQA; Critical Quality Attribute; CV; Coefficient of Variation; GA; Glatiramer Acetate; ICH; The International Conference on Harmonisation of Technical Requirements for Registration of Ph
Keywords: ویژگی کیفی بحرانی; API; active pharmaceutical ingredient; CPP; critical process parameter; CQA; critical quality attribute; D; diameter of the extruder screws; DOE; design of experiments; GSD; granule size distribution; IQR; interquartile range; L/S-ratio; liquid to solid r
Keywords: ویژگی کیفی بحرانی; NIRS; near infrared spectroscopy; PAT; process analytical technology; TDS; transdermal drug delivery systems; NIR; near infra-red; CQA; critical quality attribute; PLS; partial least square; %PE; % prediction error; MCT; mercury-cadmium-telluride; MC; Mea
Keywords: ویژگی کیفی بحرانی; aAPC; artificial APC; ACT; adoptive cell therapy; CDM; chemically defined media; cGMP; current Good Manufacturing Practices; DC; dendritic cell; CPP; critical process parameter; CQA; critical quality attribute; FACS; fluorescence activated cell sorting; H
Identification and characterization of monoclonal antibody fragments cleaved at the complementarity determining region using orthogonal analytical methods
Keywords: ویژگی کیفی بحرانی; CE-SDS; sodium dodecyl sulfate capillary electrophoresis; mAb; monoclonal antibody; RP-LC-MS; reversed phase liquid chromatography mass spectrometry; CDR; complementarity determining region; SEC-HPLC; size exclusion liquid chromatography; dSEC-HPLC; d
Keywords: ویژگی کیفی بحرانی; ANN; artificial neural networks; API; active pharmaceutical Ingredient; CFD; computational fluid dynamics; CMA; critical material attribute; CQA; critical quality attribute; CPP; critical process parameter; DEM; discrete element Method; DoDE; design of dy
Keywords: ویژگی کیفی بحرانی; stability; antibody-drug conjugate; immunoconjugate; degradation; aggregation; analytical; physicochemical; critical quality attribute;
Keywords: ویژگی کیفی بحرانی; biotechnology; formulation; HPLC; multivariate analysis; oxidation; factorial design; protein aggregation; protein formulation; proteins; stability; AC; acceptance criterion; Buff; buffer concentration; CQA; critical quality attribute; CI; confidence inte
Keywords: ویژگی کیفی بحرانی; Quality by design; Critical quality attribute; Risk ranking and filtering;
Keywords: ویژگی کیفی بحرانی; API; active pharmaceutical ingredient; Cmax; maximum plasma concentration; CQA; critical quality attribute; CPP; critical process parameter; EMA; European Medicines Agency; FDA; U.S. Food and Drug Administration; FPF; fine particle fraction; ICH; Internat
Keywords: ویژگی کیفی بحرانی; Design space; Process robustness; Ethanol precipitation; Danhong injection; Quality by design; AC; active ingredient content (mg gâ1); ACR; active ingredient recovery (%); AEA; the amount of ethanol added (mL gâ1); ANOVA; analysis of variance; ARD;
Q-marker based strategy for CMC research of Chinese medicine: A case study of Panax Notoginseng saponins
Keywords: ویژگی کیفی بحرانی; Q-marker; Chinese medicine; CMC; PNS; Manufacture processes; Q-marker; quality-marker; CM; Chinese medicine; PNS; Panax Notoginseng Saponins; CMC; chemistry, manufacturing and control; CQA; critical quality attribute; CPP; critical process parameter; ANN;
Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation
Keywords: ویژگی کیفی بحرانی; Quality by design; Risk assessment; Bilayer tablet; Optimization; Critical quality attribute; Bioequivalence;
Lyophilized Drug Product Cake Appearance: What Is Acceptable?
Keywords: ویژگی کیفی بحرانی; lyophilization; processing; freeze drying; protein formulation; drying; formulation; glass transition; stability; amorphous; CQA; critical quality attribute; Tc; collapse temperature; Tgâ²; glass transition temperature of the maximally freeze-concentrate
N+1 Engineering of an Aspartate Isomerization Hotspot in the Complementarity-Determining Region of a Monoclonal Antibody
Keywords: ویژگی کیفی بحرانی; biotechnology; monoclonal antibody; critical quality attribute; developability; isomerization; engineering;
A design space exploration for control of Critical Quality Attributes of mAb
Keywords: ویژگی کیفی بحرانی; Design space; Critical quality attribute; Critical process parameter
Optimization of a pharmaceutical tablet formulation based on a design space approach and using vibrational spectroscopy as PAT tool
Keywords: ویژگی کیفی بحرانی; AA; average assay; API; active pharmaceutical ingredient; AV; acceptance value; CI; Carr index; CMA; critical material attribute; CQA; critical quality attribute; CU; content uniformity; DHI; distributional homogeneity index; DoE; design of experiments; H
Optimization of Panax notoginseng extraction process using a design space approach
Keywords: ویژگی کیفی بحرانی; AEA; amount of ethanol added (mL/g); ANOVA; analysis of variance; ARD; average relative deviation (%); C; saponin concentration; Cal; calculated values; CPP; critical process parameter; CQA; critical quality attribute; DM; the dry matter content of an ext
Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation
Keywords: ویژگی کیفی بحرانی; API; active pharmaceutical ingredient; Cmax; maximum plasma concentration; CQA; critical quality attribute; CPP; critical process parameter; EMA; European Medicines Agency; FDA; Food and Drug Administration; HA; sodium hyaluronate; ICH; International Conf
Polyoxylglycerides and glycerides: Effects of manufacturing parameters on API stability, excipient functionality and processing
Keywords: ویژگی کیفی بحرانی; Lipid-based excipient; Polyethylene glycol ester; Critical quality attribute; Drug stability; Oxidation; Chemical reactivity;
Real-time determination of critical quality attributes using near-infrared spectroscopy: A contribution for Process Analytical Technology (PAT)
Keywords: ویژگی کیفی بحرانی; SOPs; Standard Operating Procedures; PAT; Process Analytical Technology; US-FDA; United States Food and Drug Administration; NIRS; near infrared spectroscopy; HPLC; high-performance liquid chromatography; ISO; International Organization for Standardizatio
Monitoring batch-to-batch reproducibility of liquid-liquid extraction process using in-line near-infrared spectroscopy combined with multivariate analysis
Keywords: ویژگی کیفی بحرانی; TCM; traditional Chinese medicine; PAT; process analytical technology; MSPC; multivariate statistical process control; BSPC; batch statistical process control; NOC; normal operating condition; FLJ; Flos Lonicera Japonica; CQA; critical quality attribute;
A perspective on PSE in pharmaceutical process development and innovation
Keywords: ویژگی کیفی بحرانی; ANN; artificial neural network; API; active pharmaceutical ingredient; CAMD; computer-aided molecular design; CFD; computational fluid dynamics; CP; continuous processing; CPM; continuous pharmaceutical manufacturing; CPP; critical process parameter; CQA;
Human antibody Fc deamidation in vivo
Keywords: ویژگی کیفی بحرانی; Posttranslational modification; Deamidation; Critical quality attribute