دانلود مقالات ISI درباره کیفیت طراحی + ترجمه فارسی

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

Keywords: کیفیت طراحی; 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

Correlation of Structural and Macroscopic Properties of Starches with Their Tabletability Using the SM2 Approach

Keywords: کیفیت طراحی; starch; sorption isotherm; amylose degradation enthalpy; amylopectin degradation enthalpy; process analytical technology; quality by design; percent crystallinity; Heckel analysis; multivariate analysis; tablet mechanical strength;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2015 سفارش ترجمه

Implementation of quality by design principles in the development of microsponges as drug delivery carriers: Identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies

Keywords: کیفیت طراحی; Microsponges; Semisolid dosage form; Quality by design; Principal component analysis; Partial least squares; Response surface method

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2015 سفارش ترجمه

Positively charged self-nanoemulsifying oily formulations of olmesartan medoxomil: Systematic development, in vitro, ex vivo and in vivo evaluation

Keywords: کیفیت طراحی; Bioavailability; Nanomedicine; Self-nanoemulsifying; Quality by Design; Design of experiments; In vitro cytotoxicity

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2015 سفارش ترجمه

Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities

Keywords: کیفیت طراحی; Quality by Design; Design space; Iohexol; Impurities; HILIC;

دانلود رایگان متن کامل مقاله ISI 30 صفحه سال انتشار : 2015 سفارش ترجمه

Starch-based Pickering emulsions for topical drug delivery: A QbD approach

Keywords: کیفیت طراحی; Pickering emulsions; Starch granules; Quality by design; Skin application;

دانلود رایگان متن کامل مقاله ISI 30 صفحه سال انتشار : 2015 سفارش ترجمه

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

Keywords: کیفیت طراحی; 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

Implementation of QbD for the development of a vaccine candidate

Keywords: کیفیت طراحی; Vaccines; Process development; Quality by Design; FMEA;

دانلود رایگان متن کامل مقاله ISI 4 صفحه سال انتشار : 2014 سفارش ترجمه

Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms

Keywords: کیفیت طراحی; Biowaiver; Biopharmaceutic excipient classification; Pharmaceutical quality attributes; Quality by design; Lactose; Biopharmaceutic classification system

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2014 سفارش ترجمه

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating

Keywords: کیفیت طراحی; Automated microscopy; Near-infrared; Quality by Design; Coated multiparticulate; Pellet; Dissolution performance

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2014 سفارش ترجمه

Multivariate analysis of physicochemical characteristics of lipid based nanoemulsifying cilostazol-Quality by design

Keywords: کیفیت طراحی; Cilostazol; Multivariate analysis; Solubility; Quality by design; Nanoemulsion; Adsorption;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2014 سفارش ترجمه

Review of new segregation tester method by Dr. Kerry Johanson, P.E.

Keywords: کیفیت طراحی; Segregation; Spectral analysis; Product quality; Quality by design

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2014 سفارش ترجمه

Formulation of extended release cefpodoxime proxetil chitosan–alginate beads using quality by design approach

Keywords: کیفیت طراحی; Quality by design; Box–Behnken design; Cefpodoxime proxetil

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2014 سفارش ترجمه

A quality by design (QbD) case study on enteric-coated pellets: Screening of critical variables and establishment of design space at laboratory scale

Keywords: کیفیت طراحی; Fluid-bed coating; Plackett–Burman design; Box–Behnken design; Naproxen; Quality by design

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

In silico robustness testing of a compendial HPLC purity method by using of a multidimensional design space build by chromatography modeling-Case study pramipexole

Keywords: کیفیت طراحی; HPLC method development; Quality by Design; Design Space; Robustness in routine quality control; Pramipexole;

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

A quality by design approach to optimization of emulsions for electrospinning using factorial and D-optimal designs

Keywords: کیفیت طراحی; Emulsion electrospinning; Quality by design; Phase stability; Viscosity; Conductivity

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

Quality by Design approach to understand the physicochemical phenomena involved in controlled release of captopril SR matrix tablets

Keywords: کیفیت طراحی; Quality by Design; Matrix tablets; Swelling controlled release; Image analysis; Drug release mechanism; Front movements;

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

Method transfer from high-pressure liquid chromatography to ultra-high-pressure liquid chromatography. I. A thermodynamic perspective

Keywords: کیفیت طراحی; HPLC; UHPLC; Quality by design; Adsorption isotherm; Gradient elution; Omeprazole.;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2014 سفارش ترجمه

Nicotinamide pelletization by fluidized hot melt granulation: L18 Hunter design to screen high risk variables

Keywords: کیفیت طراحی; Quality by design; Fluidized hot melt granulation; Risk analysis; Nicotinamide; Hunter design;

دانلود رایگان متن کامل مقاله ISI 13 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: کیفیت طراحی; 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

Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations

Keywords: کیفیت طراحی; Quality by Design; Design Space; Chromatography modeling software DryLab®4; UHPLC method development; Ebastine;

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

Harnessing QbD, Programming Languages, and Automation for Reproducible Biology

Keywords: کیفیت طراحی; quality by design; design of experiments; programming languages; laboratory automation; reproducibility; complexity;

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2016 سفارش ترجمه

Methodology for the validation of analytical methods involved in uniformity of dosage units tests

Keywords: کیفیت طراحی; Quality by Design; Tolerance intervals; Fit for purpose; Content uniformity; Uniformity of dosage units; Analytical Target Profile

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2013 سفارش ترجمه

Toward better understanding of powder avalanching and shear cell parameters of drug–excipient blends to design minimal weight variability into pharmaceutical capsules

Keywords: کیفیت طراحی; Binary mixtures; Critical behavior; Percolation theory; Quality by Design; Capsule filling; Mass uniformity

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2013 سفارش ترجمه

Quality assessment support system and its use in pharmaceutical plant operations

Keywords: کیفیت طراحی; Quality by design; Risk information exchange; Pharmaceutical process development; Hazard and operability studies; Quality-HAZOP

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2013 سفارش ترجمه

Separation characteristics of ethanol precipitation for the purification of the water extract of medicinal plants

Keywords: کیفیت طراحی; Ethanol precipitation; Botanical medicine; Mechanism; Quality by design

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2013 سفارش ترجمه

Recent advances and further challenges in lyophilization

Keywords: کیفیت طراحی; Lyophilization; Freeze-drying; Advances; Challenges; Pharmaceutical applications; Formulation; Stability; Collapse; Quality by design

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2013 سفارش ترجمه

Quality assessment for clinical proteomics

Keywords: کیفیت طراحی; QA, quality assessment; QC, quality control; LC, liquid chromatography; MS, mass spectrometry; MS/MS, tandem mass spectrometry; SRM, selected reaction monitoring; XIC, extracted ion chromatogramQuality assessment; Quality control; Quality by design; Repea

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

Application of a Quality by Design Approach to the Cell Culture Process of Monoclonal Antibody Production, Resulting in the Establishment of a Design Space

Keywords: کیفیت طراحی; antibody; biotechnology; cell culture; design of experiments; design space; failure mode and effects analysis; mathematical models; multivariate analysis; proteins; quality by design;

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

Quality by Design approach in the development of a solvent-modified micellar electrokinetic chromatography method: Finding the design space for the determination of amitriptyline and its impurities

Keywords: کیفیت طراحی; Amitriptyline; Capillary electrophoresis; Design space; Experimental design; Impurities; Quality by Design

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2013 سفارش ترجمه

Quality by design for wet granulation in pharmaceutical processing: Assessing models for a priori design and scaling

Keywords: کیفیت طراحی; Wet granulation; Quality by Design; Regime map; Design space; Excipient variability; Scale-up

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2013 سفارش ترجمه

A Proposal for a Quality System for Herbal Products

Keywords: کیفیت طراحی; process analytical technology; quality by design; biopharmaceuticals characterization; spectroscopy; regulatory science; bioanalysis; traditional medicine; herbal products; critical control point; Gingko biloba;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2013 سفارش ترجمه

General procedure to aid the development of continuous pharmaceutical processes using multivariate statistical modeling – An industrial case study

Keywords: کیفیت طراحی; Latent variable methods; Pharmaceutical development; Continuous processing; Design space; Quality by design; Quality risk assessment; Control strategy

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2013 سفارش ترجمه

Building better drugs: developing and regulating engineered therapeutic proteins

Keywords: کیفیت طراحی; drug development; immunogenicity; drug safety; risk mitigation; quality by design

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2013 سفارش ترجمه

Validation of analytical methods involved in dissolution assays: Acceptance limits and decision methodologies

Keywords: کیفیت طراحی; Quality by Design; Tolerance intervals; Method validation; Analytical Target Profile; Acceptance limits; Dissolution methods

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

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

Keywords: کیفیت طراحی; 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

Quality by design: Impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody

Keywords: کیفیت طراحی; Lyophilization; Monoclonal antibody; IgG3κ; Quality by design; Formulation; Design of experiments;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Applying terahertz technology for nondestructive detection of crack initiation in a film-coated layer on a swelling tablet

Keywords: کیفیت طراحی; Process analytical technology; Quality by design; Terahertz; Spectroscopy; Coating; Swelling

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Rapid evaluation for heterogeneities in monoclonal antibodies by liquid chromatography/mass spectrometry with a column-switching system

Keywords: کیفیت طراحی; Monoclonal antibody; Glycan heterogeneity; LC/MS; Column-switching; Process analytical technology; Quality by design;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Introduction of diffusing wave spectroscopy to study self-emulsifying drug delivery systems with respect to liquid filling of capsules

Keywords: کیفیت طراحی; Diffusing wave spectroscopy; Microrheology; Visco-elastic; Self-emulsifying drug delivery systems; Capsules; Quality by design;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

Design space approach in the optimization of the spray-drying process

Keywords: کیفیت طراحی; Spray-drying; Design of experiments; Quality by design; Risk-based design space; Critical quality attributes; Specifications

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2012 سفارش ترجمه

A quality by design study applied to an industrial pharmaceutical fluid bed granulation

Keywords: کیفیت طراحی; Quality by Design; Process Analytical Technology; Design Space; Multivariate data analysis; Fluid bed granulation

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2012 سفارش ترجمه

Interdependence of Drug Substance Physical Properties and Corresponding Quality Control Strategy

Keywords: کیفیت طراحی; physical property; particle size; drug substance; design space; quality by design; dissolution; multivariate analysis; principle component analysis; solid dosage form; physical characterization;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2012 سفارش ترجمه

A risk management ontology for Quality-by-Design based on a new development approach according GAMP 5.0

Keywords: کیفیت طراحی; Quality risk management; Ontology; GAMP; Quality by Design; Knowledge management; Development approach

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

Quantification of protein posttranslational modifications using stable isotope and mass spectrometry

Keywords: کیفیت طراحی; Critical quality attributes; Quality by design; Mass spectrometry; Stable isotope labeling; Posttranslational modification; Quantification; Recombinant protein;

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

Quality by design approach for formulation development: A case study of dispersible tablets

Keywords: کیفیت طراحی; Quality by design; Dispersible tablets; Critical quality attributes; Risk assessment; Design space; Control strategy;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2012 سفارش ترجمه

Development of a Fluid Bed Granulation Design Space Using Critical Quality Attribute Weighted Tolerance Intervals

Keywords: کیفیت طراحی; fluid bed processing; process analytical technology; multivariate modeling; design space; quality by design;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2012 سفارش ترجمه

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

Keywords: کیفیت طراحی; Quality by Design; design space; proteins; validation; biotechnology; mathematical models; regulatory science; multivariate analysis;

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

A perspective on PSE in pharmaceutical process development and innovation

Keywords: کیفیت طراحی; 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

Modelling oligomer formation in chromatographic separations

Keywords: کیفیت طراحی; Preparative ion-exchange chromatography; Preparative displacement chromatography; Bimodal; Mixed mode; Adsorption isotherms; Quality by design; Process design simulations; Oligomer formation

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2011 سفارش ترجمه