دانلود مقالات ISI درباره کیفیت طراحی + ترجمه فارسی

A multiscale DEM-PBM approach for a continuous comilling process using a mechanistically developed breakage kernel

Keywords: کیفیت طراحی; Mill; Conical screen mill; Population balance model; Discrete element method; Multi-scale model; Quality by design;

دانلود رایگان متن کامل مقاله ISI 46 صفحه سال انتشار : 2018 سفارش ترجمه

Development of TCM-based composite particles for direct compaction by particle design

Keywords: کیفیت طراحی; 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

دانلود رایگان متن کامل مقاله ISI 47 صفحه سال انتشار : 2018 سفارش ترجمه

Dual mechanism of microenvironmental pH modulation and foam melt extrusion to enhance performance of HPMCAS based amorphous solid dispersion

Keywords: کیفیت طراحی; API; active pharmaceutical ingredient; ASD; amorphous solid dispersion; HME; Hot-melt extrusion; HPMCAS; Hydroxypropyl methylcellulose acetate succinate; PAT; Process Analytical Technology; QbD; Quality by Design; Foam melt extrusion; Amorphous solid disp

دانلود رایگان متن کامل مقاله ISI 48 صفحه سال انتشار : 2018 سفارش ترجمه

Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products

Keywords: کیفیت طراحی; Pulmonary delivery; Dry powder inhalation; Solubility; Dissolution methods; Biopharmaceutical classification; API; Active pharmaceutical ingredient; ACI; Andersen cascade impactor; ALF; alveolar lung fluid; BCS; Biopharmaceutics Classification System; iBC

دانلود رایگان متن کامل مقاله ISI 49 صفحه سال انتشار : 2018 سفارش ترجمه

Revisiting in vitro release test for topical gel formulations: The effect of osmotic pressure explored for better bio-relevance

Keywords: کیفیت طراحی; EGF; epidermal growth factor; T/B; trypan blue; QbD; quality by design; DOE; design of experiment; PBS; phosphate buffered saline; PG; poloxamer gel; P407; poloxamer 407; P188; poloxamer 188; PDGF; platelet derived growth factor; Thermoreversible gel; Des

دانلود رایگان متن کامل مقاله ISI 49 صفحه سال انتشار : 2018 سفارش ترجمه

Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters

Keywords: کیفیت طراحی; 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

دانلود رایگان متن کامل مقاله ISI 58 صفحه سال انتشار : 2018 سفارش ترجمه

An overview of experimental designs in HPLC method development and validation

Keywords: کیفیت طراحی; 2D-HPLC; two-dimensional HPLC; AEMC; anion-exchange membrane chromatography; ANOVA; analysis of variance; BBD; Box-Behnken design; CC; chaotropic chromatography; CCD; central composite Design; CEX-HPLC; cation exchange high performance liquid chromatograp

دانلود رایگان متن کامل مقاله ISI 62 صفحه سال انتشار : 2018 سفارش ترجمه

FDA pharmaceutical quality oversight

Keywords: کیفیت طراحی; Pharmaceutical quality; Quality by design; Quality manufacturing systems; Integrated quality assessment; Facility investigations; Pharmaceutical surveillance;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2017 سفارش ترجمه

Quality-by-Design (QbD) process evaluation for phytopharmaceuticals on the example of 10-deacetylbaccatin III from yew

Keywords: کیفیت طراحی; Quality by Design; Yew; Process design; Chromatography;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2017 سفارش ترجمه

Relationships between response surfaces for tablet characteristics of placebo and API-containing tablets manufactured by direct compression method

Keywords: کیفیت طراحی; Tablet; Tensile strength; Disintegration time; Response surface; Quality by design; Design of experiments;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2017 سفارش ترجمه

Retrospective Quality by Design (rQbD) applied to the optimization of orodispersible films

Keywords: کیفیت طراحی; Aqueous polymeric dispersion; Design space; Drug release; Oral thin films; Quality by design; Stability;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2017 سفارش ترجمه

Development of oral lyophilisates containing meloxicam nanocrystals using QbD approach

Keywords: کیفیت طراحی; Nanocrystals; Meloxicam; Quality by design; Oral lyophilisates; High-pressure homogenization;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

Original ArticleQbD based approach for optimization of Tenofovir disoproxil fumarate loaded liquid crystal precursor with improved permeability

Keywords: کیفیت طراحی; Liquid crystal precursor; Glyceryl monooleate; Tenofovir disoproxil fumarate; Quality by design; Permeation flux; Factorial design;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2017 سفارش ترجمه

Review articleNovel strategies in the oral delivery of antidiabetic peptide drugs - Insulin, GLP 1 and its analogs

Keywords: کیفیت طراحی; Diabetes; Antidiabetic peptides; Insulin; GLP-1; Nano-carriers; Polymeric nanoparticles; Solid lipid nanoparticles; Liposomes; Micelles; Quality by design;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2017 سفارش ترجمه

Development of long-circulating docetaxel loaded poly (3-hydroxybutyrate-co-3-hydroxyvalerate) nanoparticles: Optimization, pharmacokinetic, cytotoxicity and in vivo assessments

Keywords: کیفیت طراحی; Docetaxel; Quality by design; Box-Behnken design; Design of experiment; Cytotoxicity;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2017 سفارش ترجمه

A quality by design (QbD) study on enoxaparin sodium loaded polymeric microspheres for colon-specific delivery

Keywords: کیفیت طراحی; Enoxaparin sodium (PubChem CID: 772); Eudragit® FS (PubChem CID: 161546); Eudragit® RS (PubChem CID: 104931); Sodium chloride (PubChem CID: 5234); Poly(vinyl alcohol) (PubChem CID: 11199); Quality by design; Microspheres; Colon-specific delivery; Eudrag

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2017 سفارش ترجمه

Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation

Keywords: کیفیت طراحی; Quality by design; Risk assessment; Bilayer tablet; Optimization; Critical quality attribute; Bioequivalence;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2017 سفارش ترجمه

Formulation by design approach for development of ultrafine self-nanoemulsifying systems of rosuvastatin calcium containing long-chain lipophiles for hyperlipidemia management

Keywords: کیفیت طراحی; Solubility; Nanoemulsion; Bioavailability; Optimization; Quality by design; Lymphatic uptake;

دانلود رایگان متن کامل مقاله ISI 17 صفحه سال انتشار : 2017 سفارش ترجمه

Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s)

Keywords: کیفیت طراحی; 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

دانلود رایگان متن کامل مقاله ISI 19 صفحه سال انتشار : 2017 سفارش ترجمه

Research paperEnhancing biopharmaceutical performance of an anticancer drug by long chain PUFA based self-nanoemulsifying lipidic nanomicellar systems

Keywords: کیفیت طراحی; PUFA lipids; Docetaxel; Quality by design; Bi-directional permeability; P-gp efflux; Lymphatic uptake; Oral bioavailability;

دانلود رایگان متن کامل مقاله ISI 19 صفحه سال انتشار : 2017 سفارش ترجمه

Natural lipids enriched self-nano-emulsifying systems for effective co-delivery of tamoxifen and naringenin: Systematic approach for improved breast cancer therapeutics

Keywords: کیفیت طراحی; 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

دانلود رایگان متن کامل مقاله ISI 28 صفحه سال انتشار : 2017 سفارش ترجمه

Uncertainty back-propagation in PLS model inversion for design space determination in pharmaceutical product development

Keywords: کیفیت طراحی; Quality by design; Design space; Partial least-squares; Latent-variable model inversion; Pharmaceutical development;

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

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: کیفیت طراحی; 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

Formulation and optimization of controlled release powder for reconstitution for metoprolol succinate multi unit particulate formulation using risk based QbD approach

Keywords: کیفیت طراحی; Face Centered Composite Design; Failure Mode and Effects Analysis; Multi Unit Particulate System; Quality by Design; Controlled Release; Metoprolol Succinate; Critical Quality Attributes (CQAs); Face Centered Composite design (FCCD); Failure Mode and Effe

دانلود رایگان متن کامل مقاله ISI 50 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: کیفیت طراحی; 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

Mechanistic approach in powder blending PAT: Bi-layer mixing and asymptotic end point prediction

Keywords: کیفیت طراحی; Powder mixing; Convection; Blend uniformity; NIR; Process analytical technology; Quality by design;

دانلود رایگان متن کامل مقاله ISI 52 صفحه سال انتشار : 2017 سفارش ترجمه

Applying quality by design principles to the small-scale preparation of the bone-targeting therapeutic radiopharmaceutical rhenium-188-HEDP

Keywords: کیفیت طراحی; Rhenium-188-HEDP; Therapeutic radiopharmaceutical; Preparation; Quality control; Quality by design; ICH Q8; Proven acceptable ranges

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2016 سفارش ترجمه

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)

Keywords: کیفیت طراحی; Process analytical technology; Quality by Design; Training; Education; Continuing professional development

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2016 سفارش ترجمه

Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets

Keywords: کیفیت طراحی; FMEA; Carvedilol; Compression coating; Quality by design

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2016 سفارش ترجمه

Cyclodextrin- and solvent-modified micellar electrokinetic chromatography for the determination of captopril, hydrochlorothiazide and their impurities: A Quality by Design approach

Keywords: کیفیت طراحی; Capillary electrophoresis; Cis-trans isomerization; Combined dosage form; Experimental design; Impurities; Quality by Design

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2016 سفارش ترجمه

Introduction to the application of QbD principles for the development of monoclonal antibodies

Keywords: کیفیت طراحی; Quality by Design;

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

A Quality by design (QbD) approach on starch-based nanocapsules: A promising platform for topical drug delivery

Keywords: کیفیت طراحی; Starch; Nanocapsules; Quality by design; Topical application; Skin

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

Enantioseparation and impurity determination of ambrisentan using cyclodextrin-modified micellar electrokinetic chromatography: Visualizing the design space within quality by design framework

Keywords: کیفیت طراحی; Ambrisentan; Capillary electrophoresis; Chiral separation; Experimental design; Impurities; Quality by design;

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

Suppression of protein inactivation during freezing by minimizing pH changes using ionic cryoprotectants

Keywords: کیفیت طراحی; Protein cryopreservation; Freezing/thawing; Protein aggregation; Protein stability; Quality by design; Freezing stress; Freezing-induced pH shift

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

Integration of QbD risk assessment tools and overall risk management

Keywords: کیفیت طراحی; Quality by design;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2016 سفارش ترجمه

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

Keywords: کیفیت طراحی; 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

Establishing a control system using QbD principles

Keywords: کیفیت طراحی; Quality by design; Critical quality attributes; Control strategy;

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

Aripiprazole loaded poly(caprolactone) nanoparticles: Optimization and in vivo pharmacokinetics

Keywords: کیفیت طراحی; Aripiprazole; Poly(caprolactone); Quality by design; Design space; Intranasal; Schizophrenia; Nanoprecipitation method;

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

Intranasal delivery of venlafaxine loaded nanostructured lipid carrier: Risk assessment and QbD based optimization

Keywords: کیفیت طراحی; Quality by design; Risk assessment; Venlafaxine; NLC; Intranasal route

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

Modeling and simulation of anion-exchange membrane chromatography for purification of Sf9 insect cell-derived virus-like particles

Keywords: کیفیت طراحی; Quality by design; Membrane chromatography; Predictive modeling; Downstream processing; Virus-like particle vaccine; High-throughput process development;

دانلود رایگان متن کامل مقاله ISI 35 صفحه سال انتشار : 2016 سفارش ترجمه

A quality control method enhancement concept-Continual improvement of regulatory approved QC methods

Keywords: کیفیت طراحی; Method enhancement concept; Quality by design; Continual improvement; HPLC; Method transfer;

دانلود رایگان متن کامل مقاله ISI 39 صفحه سال انتشار : 2016 سفارش ترجمه

Knowledge management in the QbD paradigm: manufacturing of biotech therapeutics

Keywords: کیفیت طراحی; knowledge management; quality by design; bioprocessing

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2015 سفارش ترجمه

Development of a NIR-based blend uniformity method for a drug product containing multiple structurally similar actives by using the quality by design principles

Keywords: کیفیت طراحی; Near infrared spectroscopy; Process analytical technology; Quality by design; Blend uniformity; Principal component analysis; Partial least squares regression

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2015 سفارش ترجمه

Gas chromatographic method for the determination of lumefantrine in antimalarial finished pharmaceutical products

Keywords: کیفیت طراحی; antimalaria; gas chromatographic assay coupled to flame ionization detector; lumefantrine; N,O-bis(trimethyl-silyl)trifluoro-acetamide derivatization; quality by design

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2015 سفارش ترجمه

Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: Development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride

Keywords: کیفیت طراحی; Capillary electrophoresis; Chiral separation; Enantiomeric impurity; Experimental design; Levosulpiride; Quality by design

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2015 سفارش ترجمه

Dropwise Additive Manufacturing of Pharmaceutical Products for Melt-Based Dosage Forms

Keywords: کیفیت طراحی; process analytical technology; solid dispersion; drug delivery systems; dissolution; polymers; processing; quality by design; surfactants; solid dosage form; oral drug delivery;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2015 سفارش ترجمه

Critical attributes of formulation and of elaboration process of PLGA-protein microparticles

Keywords: کیفیت طراحی; ALB; albumin; BCA; bicinchoninic acid; BSA; bovine serum albumin; DCM; dichloromethane; DMEM; Dulbecco's modified Eagle's medium; DMSO; dimethylsulfoxide; MP; microparticles; OD; optical density; PAO; phenylarsine oxide; PBS; phosphate buffered saline

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

Predicting the dissolution behavior of pharmaceutical tablets with NIR chemical imaging

Keywords: کیفیت طراحی; Dissolution testing; Disintegrant; Near infrared chemical imaging; Quality by design; Multivariate data analysis; Kollidon CL;

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

Optimization of Panax notoginseng extraction process using a design space approach

Keywords: کیفیت طراحی; 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

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

Keywords: کیفیت طراحی; 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