دانلود مقالات ISI درباره کیفیت طراحی + ترجمه فارسی

Expanding the term “Design Space” in high performance liquid chromatography (I)

Keywords: کیفیت طراحی; Quality by Design; Design Space; 3-D computer modeling software; HPLC method development; Snyder–Dolan hydrophobic subtraction model of RPLC phase selectivity

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2011 سفارش ترجمه

Isolation and characterization of therapeutic antibody charge variants using cation exchange displacement chromatography

Keywords: کیفیت طراحی; Displacement chromatography; Ion-exchange chromatography; Monoclonal antibody; Quality by design; Antibody charge variants

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

An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation

Keywords: کیفیت طراحی; Quality by Design; Discrete element method; Blending; Double cone mixer; Content uniformity; Design space

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

Performance-Based Quality Specifications: The Relationship Between Process Critical Control Parameters, Critical Quality Attributes, and Clinical Performance

Keywords: کیفیت طراحی; Monte Carlo; simulations; content uniformity; dissolution; toxicity; risk assessment; quality; quality by design; design space; theophylline;

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

Terahertz In-Line Sensor for Direct Coating Thickness Measurement of Individual Tablets During Film Coating in Real-Time

Keywords: کیفیت طراحی; coating; processing; unit operations; formulation; coating thickness; analysis; terahertz pulsed imaging; in-line sensor; quality by design; process analytical technology;

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

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

Keywords: کیفیت طراحی; quality by design; process analytical technology; design of experiments; design space; analytical chemistry; viscosity; hydrogel;

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

Quality by design approach of a pharmaceutical gel manufacturing process, part 2: Near infrared monitoring of composition and physical parameters

Keywords: کیفیت طراحی; quality by design; process analytical technologies; design space; analytical chemistry; near‐infrared spectroscopy; partial least squares; multivariate analysis; hydrogel; normal operation conditions;

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

A priori performance prediction in pharmaceutical wet granulation: Testing the applicability of the nucleation regime map to a formulation with a broad size distribution and dry binder addition

Keywords: کیفیت طراحی; Wet granulation; Quality by design; Gabapentin; Wetting and nucleation; Regime map

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manufacturing of silicone-based drug reservoirs

Keywords: کیفیت طراحی; Vibrational spectroscopy; Silicone-based drug reservoirs; Quality by Design; Process Analytical Technology; Chemometrics; Validation

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space

Keywords: کیفیت طراحی; Antimalarial drugs; Counterfeit; Design of experiments; Design space; Quality by design; Independent component analysis

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Prediction of roller compacted ribbon solid fraction for quality by design development

Keywords: کیفیت طراحی; Roller compaction; Quality by design; Solid fraction; Ribbon; Modeling; Pharmaceutical

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2011 سفارش ترجمه

Overall impact of the regulatory requirements for genotoxic impurities on the drug development process

Keywords: کیفیت طراحی; Genotoxic impurities; ICH guidelines; GTI toxicological assessment; GTI analysis; Analytical control strategy; Quality by design

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2011 سفارش ترجمه

Breakout session summary from AAPS/CRS joint workshop on critical variables in the in vitro and in vivo performance of parenteral sustained release products

Keywords: کیفیت طراحی; Parenteral; Long acting; Sustained release; Modified release; In vitro drug release testing; Microsphere; Liposome; Implant; In situ forming implant; Lipophilic solution; In vivo-in vitro relationship; Quality by design

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2010 سفارش ترجمه

Drug product modeling predictions for scale-up of tablet film coating—A quality by design approach

Keywords: کیفیت طراحی; Quality by design; Tablet film coating; Scale-up; Thermodynamics; Atomization; Process models

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2010 سفارش ترجمه

Multivariate statistical approach to optimizing sustained-release tablet formulations containing diltiazem hydrochloride as a model highly water-soluble drug

Keywords: کیفیت طراحی; Simultaneous optimization; Confidence interval; Sustained release; Highly water-soluble drug; Hydrophilic matrix tablet; Quality by design

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2010 سفارش ترجمه

Different modes of dynamic image analysis in monitoring of pharmaceutical dry milling process

Keywords: کیفیت طراحی; Process analytical technology (PAT); Conical mill; Process analyzers; Dynamic image analysis; Shape factor; Quality by design

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: کیفیت طراحی; 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

Multivariate wavelet texture analysis for pharmaceutical solid product characterization

Keywords: کیفیت طراحی; Multivariate wavelet texture analysis; Drug product; PLS; PCA; Quality by Design; Design space

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2010 سفارش ترجمه

Handling uncertainty in the establishment of a design space for the manufacture of a pharmaceutical product

Keywords: کیفیت طراحی; Design space; Quality by Design; Latent variable methods; Uncertainty; Pharmaceuticals; Partial least squares

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2010 سفارش ترجمه

Accelerating Proof of Concept for Small Molecule Drugs Using Solid-State Chemistry

Keywords: کیفیت طراحی; proof of concept; solid-state chemistry; polymorphs; salts; co-crystals; amorphous; solubility; stability; quality by design; translational science; biomarker

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2010 سفارش ترجمه

A New Definition of Pharmaceutical Quality: Assembly of a Risk Simulation Platform to Investigate the Impact of Manufacturing/ Product Variabcpility on Clinical Performance

Keywords: کیفیت طراحی; Monte Carlo; simulations; content uniformity; dissolution; toxicity; risk assessment; quality; pharmaceutical quality; quality by design; theophylline;

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2010 سفارش ترجمه

Reaction kinetics and optimization of the copper-catalyzed oxidation of ApoA-1M

Keywords: کیفیت طراحی; Reaction kinetics; Catalysis; Protein oxidation; Pharmaceuticals; Apolipoprotein; Process optimization; Quality by design;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2009 سفارش ترجمه

Deconvolution of Chemical Physical Information from Intact Tablets NIR Spectra: Two-Three-Way Multivariate Calibration Strategies for Drug Quantitation

Keywords: کیفیت طراحی; quality by design; process analytical technology; near infrared spectroscopy; PARAFAC; partial least squares;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2009 سفارش ترجمه

Quality by design approach to understand the process of nanosuspension preparation

Keywords: کیفیت طراحی; Quality by design; Nanosuspensions; Milling; Optimization; Screening; Factorial design

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2009 سفارش ترجمه

Quality by design—Thermodynamic modelling of chromatographic separation of proteins

Keywords: کیفیت طراحی; Adsorption isotherms; Computer simulation; Protein purification; Ion-exchange; Hydrophobic chromatography; IEC; HIC; PAT; Quality by design

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

Quality by design – Spray drying of insulin intended for inhalation

Keywords: کیفیت طراحی; Spray drying; Insulin; Inhalation; Design of experiments; Multivariate data analysis; Quality by design; Particle characteristics

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2008 سفارش ترجمه

A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)

Keywords: کیفیت طراحی; Liquid chromatography; Ion-pairing; Quality by design; System suitability; Column equivalence; In situ degradation; Atomoxetine

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2008 سفارش ترجمه

Quality by Design, Part I: Application of NIR Spectroscopy to Monitor Tablet Manufacturing Process

Keywords: کیفیت طراحی; near infrared spectroscopy; NIR; vibrational spectroscopy; Chemometric modeling; quality by design; orbifloxacin; compression force; crushing strength; partial least square regression; PLS;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2008 سفارش ترجمه

Development, modelling, optimisation and scale-up of chromatographic purification of a therapeutic protein

Keywords: کیفیت طراحی; Protein purification; Resin screening; Adsorption isotherms; Computer simulation; Scale-up; Preparative chromatography; PAT; Quality by design

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2007 سفارش ترجمه

Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box–Behnken design and desirability function

Keywords: کیفیت طراحی; Quality by design; Cyclosporine; Self-nanoemulsification; Box–Behnken; Optimization

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2007 سفارش ترجمه

Recent Advances in Crystallization control: An Industrial Perspective

Keywords: کیفیت طراحی; crystallizaton; PAT; quality by design; PSD; crystal habit; polymorph control

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2007 سفارش ترجمه

A quality evaluation strategy for multi-sourced active pharmaceutical ingredient (API) starting materials

Keywords: کیفیت طراحی; Liquid chromatography; API starting material; Ion-pairing; Quality by design; Impurity profiling; Perchlorate; Use test; Propinquity; Specifications; LC–MS

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2006 سفارش ترجمه

Current and future issues in the manufacturing and development of monoclonal antibodies

Keywords: کیفیت طراحی; Monoclonal antibodies; Manufacturing; Product testing; Biological characterization; Quality by design

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2006 سفارش ترجمه