Keywords: ویژگی های کیفیت بحرانی; Biotherapeutics; Gene and cell therapy; Pharmacokinetics; Non-clinical safety; Immunogenicity; Cross-reactive species; ATMP; advanced therapy medicinal products; CAR; chimeric antigen receptor; CD; cluster of differentiation; CMC; chemistry manufacturing
مقالات ISI ویژگی های کیفیت بحرانی (ترجمه نشده)
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در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: ویژگی های کیفیت بحرانی; Critical quality attributes; Functional property; Percolation threshold; Compressibility; Compactibility; Tabletability;
Keywords: ویژگی های کیفیت بحرانی; quality by design; quality target product profile; critical quality attributes; critical material attributes; critical process parameters;
Keywords: ویژگی های کیفیت بحرانی; L/S; liquid-to-solid; LOD; loss-on-drying; PBM; Population Balance Model; V0; bulk volume; V500; tapped volume after 500 taps; Ïb; bulk density; Ït; tapped density after 500 taps; Continuous manufacturing; Fluid bed drying; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; Polymeric film; Poorly water-soluble drug; Micronized drug powders; Surface modification; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; AMMS; accurate mass spectrometry; AQbD; analytical quality-by-design; ASME; American Society of Mechanical Engineers; ATP; analytical target profile; CQA; critical quality attributes; DoE; design of experiments; DQ; design qualification; DS; design space;
Keywords: ویژگی های کیفیت بحرانی; Metabolic flux analysis; Sensitivity analysis; Complex raw material; Filamentous fungi; Corn steep liquor; Key material attributes; ACV; L-α-aminoadipyl-L-cysteinyl-D-valine; CMA; critical material attributes; CPP; critical process parameters; CQA; criti
Keywords: ویژگی های کیفیت بحرانی; Nanocrystals; (Nano-)cocrystals; Characterization; Solid state; Drug release; Particle size; CQA; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; Dry granulation; Roller compaction; Milling; Flowsheet modeling; Pharmaceutical manufacturing; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; API; active pharmaceutical ingredient; BD; bulk density; CGMPs; current good manufacturing practices; CI; Carr Index; CQAs; critical quality attributes; DoE; design of experiments; EMA; European medicines agency; FDA; food and drug administration; GKF; ge
Keywords: ویژگی های کیفیت بحرانی; Nanosystems development; Quality by Design; Process design; Quality target product profile; Critical quality attributes; Risk assessment;
Keywords: ویژگی های کیفیت بحرانی; Piracetam; Polymorph; Wet granulation; Raman spectroscopy; Process analytical technology; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; API; active pharmaceutical ingredient; CMAs; critical material attributes; CCS; critical control strategy; CPPs; critical process parameters; CQAs; critical quality attributes; DoE; design of experiments; DS; design space; ICH; International Council for H
Comparability study of Rituximab originator and follow-on biopharmaceutical
Keywords: ویژگی های کیفیت بحرانی; AA; amino acid; ABC; ammonium bicarbonate; ACN; acetonitrile; ADCC; antibody-dependent cellular cytotoxicity; CD; circular dichroism; CDC; complement-dependent cytotoxicity; CDRs; complementarity determining regions; CH; constant region of heavy chain; CH
Keywords: ویژگی های کیفیت بحرانی; AE; Acoustic Emission; ANN; Artificial Neural Networks; API; Active Pharmaceutical Ingredient; BET; Brunauer-Emmett-Teller; CFD; Computational Fluid Dynamics; CIP; Constrained Interpolation Profile; CQA; Critical Quality Attributes; DEM; Discrete Elem
Keywords: ویژگی های کیفیت بحرانی; Oral disintegrating films; Quality by design; Process variables; Formulation; Film former; Lamotrigine; Critical quality attributes;
Keywords: ویژگی های کیفیت بحرانی; continuous manufacturing; direct compression; control strategy; state of control; statistical process control; process capability; CM; continuous manufacturing; Cpk; process capability index; CQA; critical quality attributes; CU; content uniformity; DC; d
Keywords: ویژگی های کیفیت بحرانی; Bio therapeutic; Comparability; Critical quality attributes; Developing countries; Generics; Health policies; High quality biosimilars; Regulation;
Keywords: ویژگی های کیفیت بحرانی; quality by design; tablets; brivanib alaninate; design space; control strategy; critical quality attributes; critical process parameters; critical material attributes; dissolution; porosity;
Keywords: ویژگی های کیفیت بحرانی; 2D-LC; two-dimensional liquid chromatography; AA; amino acid; AC; affinity chromatography; ADC; antibody-drug conjugates; ADCC; antibody-dependent cellular cytotoxicity; AF4; asymmetric flow field fractionation; APTS; 1-aminopyrene-3,6,8-trisulfonate; Asn
Keywords: ویژگی های کیفیت بحرانی; Hypromellose (PubChem CID: 57503849); Glycerol (PubChem CID: 753)Orodispersible films; Extemporaneous pharmacy preparations; Optimizing formulation; Quality by design; Quality target product profile; Critical quality attributes
Keywords: ویژگی های کیفیت بحرانی; CCD; Central Composite Design; CF; cystic fibrosis; CQAs; Critical Quality Attributes; CPPs; Critical Process Parameters; DoE; Design of Experiments; ED; Emitted Dose; FPD; Fine Particle Dose; Amikacin sulphate (PubChem CID: 45357036); Amikacin sulphate;
Keywords: ویژگی های کیفیت بحرانی; Amorphous; Critical quality attributes; Crystallinity; Differential scanning calorimetry (DSC); Dissolution; Physical stability
Keywords: ویژگی های کیفیت بحرانی; Warfarin sodium clathrate; Amorphous; Critical quality attributes; Disintegration time; Dissolution; Crystallinity and stability;
Keywords: ویژگی های کیفیت بحرانی; Dry powder inhaler (DPI); Amikacin; Cystic fibrosis; Half-fractional factorial design; Orally inhaled drug product (OIDP); AMK; Amikacin; DPI; Dry Powder Inhaler; QbD; Quality by Design; DoE; Design of Experiments; CQAs; Critical Quality Attributes; CPPs;
Keywords: ویژگی های کیفیت بحرانی; Polymer therapeutics; Critical quality attributes; PEGylated proteins; Polymer-drug conjugates; Block copolymer micelles;
Keywords: ویژگی های کیفیت بحرانی; Inhalation powders; Low-dose capsule filling; Low-fill weight; Dosator nozzle machine; Critical quality attributes; Multivariate data analysis;
Keywords: ویژگی های کیفیت بحرانی; Orthogonal projections to latent structures; Mannitol; Dicalcium phosphate; Experimental design; Principal component analysis; Roll compaction; Tablet manufacturing; Quality by design; Critical quality attributes; Excipient quality;
Glycosimilarity assessment of biotherapeutics 1: Quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept
Keywords: ویژگی های کیفیت بحرانی; APTS; 8-aminopyrene-1,3,6-trisulfonic acid; CGE-LIF; capillary gel electrophoresis - laser induced fluorescence; CQA; critical quality attributes; ADCC; antibody-dependent cell-mediated cytotoxicity; CDC; complement-dependent cytotoxicity; Fc; fragment
Investigation of the distributional homogeneity on chlorpheniramine maleate tablets using NIR-CI
Keywords: ویژگی های کیفیت بحرانی; DHI; Distributional Homogeneity Index; CPM; chlorpheniramine maleate; NIR-CI; near infrared chemical imaging; PAT; process analysis technology; CQAs; critical quality attributes; API; active pharmaceutical ingredient; HPLC; high-performance liquid chromat
Development of TCM-based composite particles for direct compaction by particle design
Keywords: ویژگی های کیفیت بحرانی; Direct compaction; Design of experiment; Compactibility; Flowability; Yield; Traditional Chinese medicine; AHE; Andrographis herba extract; API; active pharmaceutical ingredient; AR; angle of repose; AUTCC; area under the tensile strength versus compactio
Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters
Keywords: ویژگی های کیفیت بحرانی; Granules; Paracetamol; Glycerol distearate; Size distribution; Flowability; Drug release; AAP; atomization air pressure; AUC; area under the drug release curve; BCS; Biopharmaceutics Classification System; CI; compressibility index; CPP; critical process
Nanopharmaceuticals for wound healing - Lost in translation?
Keywords: ویژگی های کیفیت بحرانی; Nanomaterials; Biomaterials; Advanced wound healing therapies; Current regulatory perspective; ASTM; American Society for Testing and Materials; CQA; critical quality attributes; ECM; extracellular matrix; EGF; epidermal growth factor; EMA; European medic
Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s)
Keywords: ویژگی های کیفیت بحرانی; NLCs; Nanostructured lipid carriers; SLNs; Solid lipid nanoparticles; CA; Cetyl alcohol; QbD; Quality by Design; FbD; Formulation by Design; CQA; Critical Quality Attributes; CMA; Critical Material Attributes; CFA; Critical Formulation Attributes; Opt; Op
Natural lipids enriched self-nano-emulsifying systems for effective co-delivery of tamoxifen and naringenin: Systematic approach for improved breast cancer therapeutics
Keywords: ویژگی های کیفیت بحرانی; SNEDDS; Self-nano-emulsifying drug delivery systems; Smix; Surfactant mix; TMX; Tamoxifen; NG; Neringenin; PUFA; Polyunsaturated fatty acids; GIT; Gastrointestinal tract; Opt; Optimized; QbD; Quality by design; DoE; Design of experiment; CQA; Critical qua
Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non)equivalence of topical semisolids: A case study of “ready-to-use” vehicles
Keywords: ویژگی های کیفیت بحرانی; Microstructure; Critical quality attributes; In vitro release; In vitro skin permeation; In vivo tape stripping; In vitro-in vivo correlation;
Assessing analytical comparability of biosimilars: GCSF as a case study
Keywords: ویژگی های کیفیت بحرانی; CQA; critical quality attributes; GCSF; granulocyte colony stimulating factor; CD; circular dichroism spectroscopy; RPC; reverse phase chromatography; SEC; size exclusion chromatography; FLD; fluorescence detector; mAbs; monoclonal antibodies; PTM; post t
Establishing a control system using QbD principles
Keywords: ویژگی های کیفیت بحرانی; Quality by design; Critical quality attributes; Control strategy;
Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic
Keywords: ویژگی های کیفیت بحرانی; quality by design; QbD; risk assessment; design space; critical quality attributes; process analytical technology; PAT
Effect of Individual Fc Methionine Oxidation on FcRn Binding: Met252 Oxidation Impairs FcRn Binding More Profoundly than Met428 Oxidation
Keywords: ویژگی های کیفیت بحرانی; monoclonal antibody; serum half-life; oxidation; critical quality attributes; neonatal Fc receptor; protein binding; surface plasmon resonance; HPLC; stability; calorimetry;
Optimization of a chromatographic process for the purification of saponins in Panax notoginseng extract using a design space approach
Keywords: ویژگی های کیفیت بحرانی; ARD; average relative deviation; BV; bed volume; CPPs; critical process parameters; CQAs; critical quality attributes; C0i; concentration of saponin i in the loading solution (mg/g); Cei; concentration of saponin i in the elution solution (mg/g); CeTS; to
A new combination approach of CI jet and QESD to formulate pH-susceptible amorphous solid dispersions
Keywords: ویژگی های کیفیت بحرانی; ASDs; Amorphous solid dispersions; BCS; Biopharmaceutics classification system; BI; Boehringer Ingelheim Pharmaceuticals; CIJ; Confined impinging jet; CQAs; Critical quality attributes; DCM; Dicholoromethane; HP-55; Hydroxypropyl methylcellulose phthalate
Design space approach in the optimization of the spray-drying process
Keywords: ویژگی های کیفیت بحرانی; Spray-drying; Design of experiments; Quality by design; Risk-based design space; Critical quality attributes; Specifications
Quantification of protein posttranslational modifications using stable isotope and mass spectrometry. II. Performance
Keywords: ویژگی های کیفیت بحرانی; Critical quality attributes; Mass spectrometry; Stable isotope labeling; Posttranslational modification; Quantification; Recombinant protein; Linear range of quantification;
Quantification of protein posttranslational modifications using stable isotope and mass spectrometry
Keywords: ویژگی های کیفیت بحرانی; Critical quality attributes; Quality by design; Mass spectrometry; Stable isotope labeling; Posttranslational modification; Quantification; Recombinant protein;
Quality by design approach for formulation development: A case study of dispersible tablets
Keywords: ویژگی های کیفیت بحرانی; Quality by design; Dispersible tablets; Critical quality attributes; Risk assessment; Design space; Control strategy;