Keywords: ایالات متحده داروسازی; biopharmaceuticals characterization; surfactants; protein formulation; NMR spectroscopy; protein aggregation; API; active pharmaceutical ingredient; D2O; deuterated water, heavy water, deuterium oxide; JP; Japanese Pharmacopeia; NMR; nuclear magnetic reso
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Keywords: ایالات متحده داروسازی; AAC; area above the curve; CDI; N,Nʹ-carbonyldiimidazole; CH; cholesterol; CH-Lip; conventional (cholesterol) liposomes; DMAP; dimethylaminopyridine; DMF; dimethylformamide; EDC; N-ethyl-Nʹ-(3-dimethylaminopropyl) carbodiimide; EE; entrapment efficiency
Keywords: ایالات متحده داروسازی; ASD; amorphous solid dispersion; AUC; area under the curve; C; supersaturated concentration of CUR; CSat; saturation solubility of CUR; CE; complexation efficiency; CHI; chitosan; CUR; curcumin; DLS; dynamic light scattering; DSC; differential scanning ca
Keywords: ایالات متحده داروسازی; Whey protein; In vitro digestion; Bioactive peptide; Glucagon-like peptide-1; Dipeptidyl peptidase IV inhibitor; Antioxidant activity; α-LA; α-lactalbumin; β-LG; β-lactoglobulin; ABAP; 2,2â²-azobis(2-methylpropionamidine) dihydrochloride; AMC; H-Gly-
Keywords: ایالات متحده داروسازی; freeze-drying/lyophilization; formulation; protein delivery; mucosal drug delivery; stabilization; solid dosage form; solid state stability; BP; British Pharmacopoeia; CG; carrageenan; EC50; half-maximal effective concentration; FDI; fast-dissolving inser
Keywords: ایالات متحده داروسازی; 2D-LC; Two Dimensional Liquid Chromatography; ADC; Antibody Drug Conjugate; AEX; Anion Exchange Chromatography; BEH; Bridged Ethylene Hybrid (hybrid silica); BSA; Bovine Serum Albumin; BsAb; Bispecific Antibody; CQA; Critical Quality Attribute; EMA; Europ
Keywords: ایالات متحده داروسازی; 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: ایالات متحده داروسازی; BCA; bicinchoninic acid; CV; coefficient of variation; EDTA; ethylenediaminetetraacetic acid; ESI; electrospray ionization; FDA; Food and Drug Administration; fu; free drug fraction; LC-MS/MS; liquid chromatography, tandem mass spectrometry; LLOQ; lower
Keywords: ایالات متحده داروسازی; Salts; Gemfibrozil; Intrinsic dissolution rate; Surface dissolution imaging; Focus variation; GEM; gemfibrozil; DSC; differential scanning calorimetry; XRPD; X-ray powder diffraction; API; active pharmaceutical ingredient; BCS; biopharmaceutical classific
Keywords: ایالات متحده داروسازی; container closure integrity testing; prefilled syringe; primary packaging; mass spectrometry-based helium leak detection; USP <1207>; CCI; container closure integrity; CCS; container closure system; CCIT; container closure integrity testing; DIN; Deutsche
Keywords: ایالات متحده داروسازی; Degradation products; Impurities; International chemical reference substances; Pharmacopoeial standards; Reference standards; Primary reference standards; Secondary reference standards; Working standards; AAS; atomic absorption spectroscopy; ANDA; abbrevi
Keywords: ایالات متحده داروسازی; amorphous; nanoparticles; nanocrystalline; solubility; stability; dissolution; solid state; calorimetry; X-ray diffraction; bioavailability; ACN; amorphous chitin nanoparticles; API; active pharmaceutical ingredient; APTES; 3-aminopropyltriethoxysilane; B
Keywords: ایالات متحده داروسازی; SA; sodium alginate; M-block; β-d-mannuronic acid unit of SA; G-blocks; α-l-guluronic acid unit of SA; CL; calcium lactate; RVS; reverse spherification; LHB; liquid-core hydrogel beads; RBJ; radish by-product juice; MAFF; Ministry of Agriculture, Forest
Keywords: ایالات متحده داروسازی; AC; activated carbon; ACS; American Chemical Society; FAME; fatty acid methyl ester; FCC; Food Chemical Codex; FFA; free fatty acid; FID; flame ionization detector; FTIR; Fourier transform infrared; GC; gas chromatography; MONG; matter organic non glycero
Keywords: ایالات متحده داروسازی; ADHD; attention hyperactive disorder; AKT; protein kinase B; AMPA; α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid; Bcl-2; B-cell lymphoma 2; BDNF; brain derived neurotrophic factor; Css; Steady state plasma concentration; D1; type 1 dopamine recept
Keywords: ایالات متحده داروسازی; AT; antithrombin; BSA; bovine serum albumin; CTA; cetyltrimethylammonium; Gal; galactose; GlcA; glucuronic acid; LMWH; low-molecular-weight heparin; NMR; nuclear magnetic resonance; SAX; strong anion exchange; USP; United States Pharmacopeia; Enoxaparin s
Keywords: ایالات متحده داروسازی; Preeclampsia; eclampsia; magnesium sulphate; chemical stability; CL2; commercially available lidocaine HCl 2%; CM50; commercially available magnesium sulphate 50%; CM50CL2; commercially available magnesium sulphate 50% combined with lidocaine; HPLC; high
Keywords: ایالات متحده داروسازی; siRNA; small interfering ribonucleic acid; Pt; platinum; PBS; phosphate buffered saline; PDMS; polydimethylsiloxane; PEG; polyethylene glycol; USP; United States Pharmacopeia; SL; stereolithography; EI; electrochemical impedance; Drug delivery; Wireless p
Keywords: ایالات متحده داروسازی; CMC; Regulatory; Cell therapy; CAT; Committee for Advanced Therapies; CCIT; container closure integrity test; CFR; Code of Federal Regulations; CLIA; Clinical Laboratory Improvement Amendments; CMC; Chemistry Manufacturing and Controls; CPMP; Committee fo
Keywords: ایالات متحده داروسازی; API; Active Pharmaceutical Ingredient; NSDS; Nipple Shield Delivery System; USP; United States Pharmacopeia; Rapidly disintegrating tablet; Texture analysis; Infant drug delivery; Breast milk; Nipple shield delivery system; NSDS;
Keywords: ایالات متحده داروسازی; DSC; Differential Scanning Calorimetry; FDM; Fused Deposition Modelling; FFF; Fused filament fabrication; SEM; Scanning Electron Microscopy; HME; Hot Melt Extrusion; HPC; hydroxypropyl cellulose; PVA; polyvinyl alcohol; TEC; triethyl citrate; TGA; Thermo
Keywords: ایالات متحده داروسازی; BCS; Biopharmaceutics Classification System; CIP; ciprofloxacin; CV; coefficient of variation; DMEM; Dulbecco's modified Eagle's medium; DMSO; dimethyl sulfoxide; EDTA; trypsin-ethylenediaminetetraacetic acid; FESEM; field emission scanning electron
Keywords: ایالات متحده داروسازی; Bioengineered heparin; One-pot synthesis; Liquid chromatography-mass spectrometry; United States Pharmacopeia; Nuclear magnetic resonance spectroscopy;
Keywords: ایالات متحده داروسازی; HPMC; hydroxypropyl methylcellulose; GG; native grewia gum; GDS; starch-free grewia gum; GGp; native grewia gum polymer; GDSp; de-starched grewia gum polymer; HPMCp; hydroxypropyl methylcellulose polymer; HPMCf; hydroxypropyl methylcellulose formulation;
Keywords: ایالات متحده داروسازی; AV; acceptance value; CIJC; confined impinging jet crystallization; DLS; dynamic light scattering; DSC; differential scanning calorimetry; ESC; encapsulation by spray coagulation; NP; nanopharmaceutical; PXRD; powder X-ray diffraction; SDS; sodium dodecyl
Keywords: ایالات متحده داروسازی; BAC; Blood alcohol content; B-BAES; Brief Biphasic Alcohol Effects Scale; CO; Carbon monoxide; DDS; dependent daily smokers; FTCD; Fagerström test for Cigarette Dependence; NNS; nondependent nondaily smokers; NRT; nicotine replacement therapy; QSU-Brief;
A comparison of in vitro cytotoxicity assays in medical device regulatory studies
Keywords: ایالات متحده داروسازی; Cytotoxicity; Medical device; Qualitative and quantitative; MTT/XTT; tetrazolium; NR; neutral red; CFA; colony formation assay; MEM; minimal essential medium; HTS; high throughput screening; MHLW; Japan Ministry of Health Labour and Welfare; USP; United S
Microencapsulation of lutein by spray-drying: Characterization and stability analyses to promote its use as a functional ingredient
Keywords: ایالات متحده داروسازی; RH; relative humidity; AMD; age-related macular degeneration; SFE; supercritical fluid extraction; USP; United States Pharmacopeia; YE; yield of encapsulation; EE; encapsulation efficiency; HPLC; high-performance liquid chromatography; DAD; diode-array de
Mechanistic Physiologically Based Pharmacokinetic Modeling of the Dissolution and Food Effect of a Biopharmaceutics Classification System IV Compound-The Venetoclax Story
Keywords: ایالات متحده داروسازی; amorphous; absorption, distribution, metabolism, and excretion (ADME); bioavailability; food effect; physiologically based pharmacokinetic modeling; clinical pharmacokinetics; intestinal absorption; passive diffusion/transport; drug interaction; ASD; Amor
Preparation of a crystalline salt of indomethacin and tromethamine by hot melt extrusion technology
Keywords: ایالات متحده داروسازی; Crystalline salt; Indomethacin; Tromethamine; Hot melt extrusion; Solution-phase NMR; hot melt extrusion; HME; solvent evaporation; SE; differential scanning calorimetry; DSC; hot-stage polarized light microscopy; HSPLM; Fourier transform infrared spectro
Quality specifications for articles of botanical origin from the United States Pharmacopeia
Keywords: ایالات متحده داروسازی; United States Pharmacopeia; Botanical dietary supplements; Herbal medicines; High-performance liquid chromatography identification; High-performance thin-layer chromatography identification; Specifications for botanicals; DI; dietary ingredients; DS; diet
Urine metabolomics shows an induction of fatty acids metabolism in healthy adult volunteers after supplementation with green coffee (Coffea robusta L.) bean extract
Keywords: ایالات متحده داروسازی; Green coffee; Metabolomics; Urine; Caffeoyl quinic acid; GCBE; Green coffee bean extract; CGA; Chlorogenic acid; PPAR-α; Peroxisome proliferator-activated receptors α; 8-OHdG; 8-Hydroxydeoxyguanosine; LC; Liquid Chromatography; MS; Mass Spectrometry; UP
An overview of experimental designs in HPLC method development and validation
Keywords: ایالات متحده داروسازی; 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
Use of biorelevant dissolution and PBPK modeling to predict oral drug absorption
Keywords: ایالات متحده داروسازی; Biorelevant dissolution; Weak base; PBPK modeling; BCS class II; pH dependent solubility; ACAT; advanced compartmental absorption and transit model; ADAM; advanced dissolution, absorption and metabolism model; API; active pharmaceutical ingredient; ASD;
Parent heparin and daughter LMW heparin correlation analysis using LC-MS and NMR
Keywords: ایالات متحده داروسازی; Low molecular weight heparin; Parent heparin; Liquid chromatography mass spectrometry; Nuclear magnetic resonance; Correlation; LMWH; Low Molecular Weight Heparin; OSCS; Over-sulfated chondroitin sulfate; USP; United States Pharmacopeia; PNNL; Pacific Nor
Simultaneous spectrophotometric determination of glimepiride and pioglitazone in binary mixture and combined dosage form using chemometric-assisted techniques
Keywords: ایالات متحده داروسازی; C; Concentration matrix; C*; new concentration matrix; CLS; classical least-squares; CRACLS; Concentration residual augmented classical least-squares; GLM; Glimepiride; ILS; inverse least-squares; PCR; principal component regression; PIO; Pioglitazone; PL
The Evaluation of In Vitro Drug Dissolution of Commercially Available Oral Dosage Forms for Itraconazole in Gastrointestinal Simulator With Biorelevant Media
Keywords: ایالات متحده داروسازی; precipitation; supersaturation; Caco-2 cells; dissolution; formulation; gastrointestinal; in vitro/in vivo correlations; intestinal absorption; permeability; cyclodextrins; AUC; area under the curve; AUDC; area under the dissolved drug amount-time curve
Establishment of chondroitin B lyase-based analytical methods for sensitive and quantitative detection of dermatan sulfate in heparin
Keywords: ایالات متحده داروسازی; ChonB; chondroitin B lyase; CP; Chinese Pharmacopoeia; CS; chondroitin sulfate; DS; dermatan sulfate; E.coli; Escherishchia coli; EP; European Pharmacopoeia; GAG; glycosaminoglycan; GalNAc4S; 4-O-sulfo-α-d-N-acetylgalactosamine; GlcNS6S; 6-O-sulfo-N-sulf
Calendering as a direct shaping tool for the continuous production of fixed-dose combination products via co-extrusion
Keywords: ایالات متحده داروسازی; Calendering; Co-extrusion; Continuous production; Fixed-dose combination product; Sustained release; Immediate release; HME; hot-melt extrusion; FDC; fixed-dose combination; MPT; metoprolol tartrate; HCT; hydrochlorothiazide; EC; ethylcellulose; PEO; poly
Yarrowia lipolytica Lipase 2 Is Stable and Highly Active in Test Meals and Increases Fat Absorption in an Animal Model of Pancreatic Exocrine Insufficiency
Keywords: ایالات متحده داروسازی; Chronic Pancreatitis; Enzyme Therapy; Fat Digestion; Lipolysis; CFA; coefficient of fat absorption; FFA; free fatty acid; HGL; human gastric lipase; MAG; monoglyceride; PEI; pancreatic exocrine insufficiency; PERT; pancreatic enzyme replacement therapy; P
Cryopreservation of human monocytes for pharmacopeial monocyte activation test
Keywords: ایالات متحده داروسازی; BET; bacterial endotoxins test; BSA; bovine serum albumin; DPBS; Dulbecco's phosphate buffered saline; ECVAM; European Centre for the Validation of Alternative Methods; EDQM; European Directorate for the Quality of Medicines & Health Care; ELISA; enzyme-l
Novel semisolid SNEDDS based on PEG-30-dipolyhydroxystearate: Development and characterization
Keywords: ایالات متحده داروسازی; %T; percentage transmittance; 1H NMR; proton nuclear magnetic resonance; aN; hyperfine coupling constant; D2O; deuterium oxide; dB; decibel; d-DMSO; deuterated dimethyl sulfoxide; DLS; dynamic light scattering; DPHS; Cithrol® DPHS; DSC; differential scan
Phase II, dose ranging study of the safety and immunogenicity of single dose West Nile vaccine in healthy adults â¥50 years of age
Keywords: ایالات متحده داروسازی; AE; adverse event; AR; adverse reaction; AUC; area under the curve; E; envelope; GMT; geometric mean titer; Cmax; maximum concentration; PRNT; plaque reduction neutralization test; prM; pre-membrane; SAE; serious adverse event; SOC; system organ class; US
Neurometabolic mechanisms for memory enhancement and neuroprotection of methylene blue
Keywords: ایالات متحده داروسازی; AD; Alzheimer's disease; ATP; adenosine triphosphate; FADH2; flavin adenine dinucleotide; GCL; ganglion cell layer; MB; methylene blue; MCI; mild cognitive impairment; MMA; methylmalonate; NADH; nicotine adenine dinucleotide; NADPH; nicotine adenine dinuc
Chronic Pancreatitis and Persistent Steatorrhea: What Is the Correct Dose of Enzymes?
Keywords: ایالات متحده داروسازی; Chronic Pancreatitis; Exocrine Pancreatic Insufficiency; Pancreatic Enzyme Replacement Therapy; BMI; body mass index; CFA; coefficient of fat absorption; FDA; Food and Drug Administration; MTG; mixed triglyceride; RBP; retinol binding protein; USP; United
Potential Clinical Impact of Compounded Versus Noncompounded Intrathecal Baclofen
Keywords: ایالات متحده داروسازی; Pharmacy; Rehabilitation; FDA; Food and Drug Administration; ITB; intrathecal baclofen; USP; United States Pharmacopeia;
The pharmacopeial evolution of intralipid injectable emulsion in plastic containers: From a coarse to a fine dispersion
Keywords: ایالات متحده داروسازی; United States Pharmacopeia; Chapter <729>; Light scattering; Light obscuration; Mean droplet diameter; Percent fat > 5 μm; Intralipid
Incidence of Hypertriglyceridemia in Critically Ill Neonates Receiving Lipid Injectable Emulsions in Glass Versus Plastic Containers: A Retrospective Analysis
Keywords: ایالات متحده داروسازی; BL; Birth length; BW; Birth weight; DOL; Day of life (from birth); EFA; Essential fatty acid; FDA; Food and Drug Administration; G; Glass; GA; Gestational age; GIR; Glucose infusion rate; IV; Intravenous; P; Plastic; PFAT5; Volume-weighted percent of fat
In-Process 20-Minute Endotoxin “Limit Test” for Positron Emission Tomography Radiopharmaceuticals
Keywords: ایالات متحده داروسازی; Bacterial endotoxins test; nuclear pharmacy; positron emission tomography; United States Pharmacopeia;
Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities
Keywords: ایالات متحده داروسازی; United States Pharmacopeia; Reference Standards; Specifications; USP–NF; Metrology; Monographs