دانلود مقالات ISI درباره Qbd + ترجمه فارسی

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes

Keywords: AFE; Average Fold Error; AAFE; Absolute Average Fold Error; API; Active pharmaceutical ingredient; AUC; Area under the curve; BCS; Biopharmaceutics classification system; BE; Bioequivalence; BP; Blood-to-plasma ratio; CCC; Concordance Correlation Coeffici

دانلود رایگان متن کامل مقاله ISI 49 صفحه سال انتشار : 2017 سفارش ترجمه

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

Keywords: API; Active pharmaceutical ingredient; AUC; Area under the curve; BCS; Biopharmaceutics classification system; BE; Bioequivalence; BP; Blood-to-plasma ratio; CL; Clearance; CL/F; Apparent clearance; Cmax; Maximum concentration; Do; Dose number; fa; Fracti

دانلود رایگان متن کامل مقاله ISI 50 صفحه سال انتشار : 2017 سفارش ترجمه

Optimization of ciprofloxacin complex loaded PLGA nanoparticles for pulmonary treatment of cystic fibrosis infections: Design of experiments approach

Keywords: ACN; acetonitrile; CF; cystic fibrosis; DMSO; dimethyl sulfoxide; DoE; design-of-experiments; EE%; encapsulation efficiency%; MJR; microjet reactor; NP; nanoparticle; PDI; polydispersity index; PLGA; poly(lactic-co-glycolic) acid; QbD; quality-by-design;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2016 سفارش ترجمه

QbD implementation and Post Approval Lifecycle Management (PALM)

Keywords: QbD; Implementation; Lifecycle management; Design space; Change control; Process monitoring;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2016 سفارش ترجمه

Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic

Keywords: quality by design; QbD; risk assessment; design space; critical quality attributes; process analytical technology; PAT

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2016 سفارش ترجمه

Optimization of Panax notoginseng extraction process using a design space approach

Keywords: 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

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2015 سفارش ترجمه

Establishing column batch repeatability according to Quality by Design (QbD) principles using modeling software

Keywords: DOE; DryLab; QbD; Robustness; UPLC-column comparison

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2015 سفارش ترجمه

Optimization of a chromatographic process for the purification of saponins in Panax notoginseng extract using a design space approach

Keywords: 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

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2015 سفارش ترجمه

Implementation of transmission NIR as a PAT tool for monitoring drug transformation during HME processing

Keywords: API; active pharmaceutical ingredients; DSC; differential scanning calorimetry; FDA; Food and Drug Administration; HME; hot-melt extrusion; IND; indomethacin; NIR; near infrared spectroscopy; PAT; process analytical technology; PCA; principal component an

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2015 سفارش ترجمه

An efficient, maintenance free and approved method for spectroscopic control and monitoring of blend uniformity: The moving F-test

Keywords: NIR; PAT; QbD; Blend Uniformity; Process control; Dry powder mixing

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2015 سفارش ترجمه

Continuous twin-screw granulation for enhancing the dissolution of poorly water soluble drug

Keywords: Granulations; DoE; QbD; Dissolutions; Twin screw; Raman; DVS

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2015 سفارش ترجمه

Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Keywords: 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

دانلود رایگان متن کامل مقاله ISI 33 صفحه سال انتشار : 2015 سفارش ترجمه

Development of topical gel containing aceclofenac-crospovidone solid dispersion by “Quality by Design (QbD)” approach

Keywords: Topical gel; Carbopol 940; Aceclofenac; Factorial design; QbD; Optimization;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2014 سفارش ترجمه

Implementation of an advanced hybrid MPC-PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plant

Keywords: QbD; quality by design; QbT; quality by testing; PAT; process analytical technology; MPC; model predictive control; PID; proportional integral derivative; PI; proportional integral; PCA; principal component analysis; NIR; near infrared; FDA; Food and Drug

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2014 سفارش ترجمه

System-wide hybrid MPC-PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction

Keywords: Model predictive control; Hybrid control; Pharmaceutical; Continuous processing; Tablet manufacturing; QbD;

دانلود رایگان متن کامل مقاله ISI 19 صفحه سال انتشار : 2013 سفارش ترجمه

A quality by design approach for the development of lyophilized liposomes with simvastatin

Keywords: Lyophilization; Liposomes; Simvastatin; QbD;

دانلود رایگان متن کامل مقاله ISI 45 صفحه سال انتشار : 2017 سفارش ترجمه

Exploring better column selectivity choices in ultra-high performance liquid chromatography using Quality by Design principles

Keywords: Amlodipine; DoE; DryLab; QbD; UHPLC-column comparison

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2013 سفارش ترجمه

Monitoring ibuprofen-nicotinamide cocrystal formation during solvent free continuous cocrystallization (SFCC) using near infrared spectroscopy as a PAT tool

Keywords: Cocrystals; NIR spectroscopy; PAT; QbD; Process analytics; Hot melt extrusion; Twin screw extrusion; Ibuprofen; Nicotinamide;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

Establishing and analyzing the design space in the development of direct compression formulations by gene expression programming

Keywords: FDA; Food and Drug Administration; GMP; Good Manufacturing Practice; QbD; quality by design; ICH; International Conference on Harmonization; RSM; Response Surface Methodology; GEP; gene expression programming; MSE; Mean Squared Error; SRM; Structural Risk

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2012 سفارش ترجمه

Evaluation of Effects of Fc Domain High-Mannose Glycan on Antibody Stability

Keywords: monoclonal antibody; glycosylation; formulation; HPLC; chromatography; high-mannose glycans; stability; QbD;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale

Keywords: Liposome; QbD; Tenofovir; Encapsulation efficiency; Plackett-Burman; Central composite design; Response surface method (RSM); Design space;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

Pharmaceutical NanotechnologyApplication of quality by design to formulation and processing of protein liposomes

Keywords: Liposome; QbD; Superoxide dismutase; Freeze-and-thaw unilamellar vesicles (FAT-ULV); Encapsulation efficiency; D-optimal design; Design space; Risk analysis;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

A perspective on PSE in pharmaceutical process development and innovation

Keywords: 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;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2012 سفارش ترجمه

A multivariate approach for the statistical evaluation of near-infrared chemical images using Symmetry Parameter Image Analysis (SPIA)

Keywords: NIR-CI; QbD; MVA; Homogeneity; Skewness; Kurtosis

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2011 سفارش ترجمه

A quality by design (QbD) case study on liposomes containing hydrophilic API: I. Formulation, processing design and risk assessment

Keywords: Liposome; QbD; Tenofovir; Encapsulation efficiency; Particle size; Risk analysis

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2011 سفارش ترجمه

Combining microwave resonance technology to multivariate data analysis as a novel PAT tool to improve process understanding in fluid bed granulation

Keywords: Fluid bed granulation; PAT; Microwave resonance technology; Multivariate data analysis; Batch monitoring; QbD

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2011 سفارش ترجمه

A new PAT/QbD approach for the determination of blend homogeneity: Combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA)

Keywords: PAT; on-line NIRS; NIR-CI; Blending; Design space; QbD

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2011 سفارش ترجمه

Near-infrared chemical imaging (NIR-CI) for counterfeit drug identification—A four-stage concept with a novel approach of data processing (Linear Image Signature)

Keywords: NIR-CI; NIRS; Counterfeits; QbD; MVA; Homogeneity

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2010 سفارش ترجمه

Aspects of the “Design Space” in high pressure liquid chromatography method development

Keywords: Robustness of HPLC methods; Method development; Optimization; Quality by Design; Design Space; 3D-Computer modelling software; Validation; QbD; ICH Q8

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2010 سفارش ترجمه

Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett–Burman design

Keywords: CyA; PLGA; QbD; Plackett–Burman; Nanoparticles and dissolution efficiency

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2010 سفارش ترجمه

Evaluation of software sensors for on-line estimation of culture conditions in an Escherichia coli cultivation expressing a recombinant protein

Keywords: NIR, near-infrared; DO, dissolved oxygen; GFP, green fluorescence protein; PAT, process analytical technologyOn-line estimation; Software sensor; Near-infrared spectrometry; PAT; QbD

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2010 سفارش ترجمه

A tandem network with MAP inputs

Keywords: Tandem network; QBD; Level-dependent; Level-expanding; DREB method; Network sojourn time

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2008 سفارش ترجمه

An auxiliary server threshold queueing model and its application to the operational characteristics of web server system

Keywords: Auxiliary server system; QBD; Web-server

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2007 سفارش ترجمه

Performance evaluation of a multi-echelon production, transportation and distribution system: A matrix analytical approach

Keywords: Performance evaluation; Queueing; Multi-echelon; QBD

دانلود رایگان متن کامل مقاله ISI 18 صفحه سال انتشار : 2007 سفارش ترجمه