Keywords: فارماکوپه اروپایی; FPP; finished pharmaceutical product; API; active pharmaceutical ingredient; Ph. Eur.; European Pharmacopoeia; RRT; relative retention time; RSD; relative standard deviation; QC samples; quality control samples; CI; confidence interval; R2; Coefficient of
مقالات ISI فارماکوپه اروپایی (ترجمه نشده)
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Keywords: فارماکوپه اروپایی; 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: فارماکوپه اروپایی; A4D; adapter 4 dialysis; API; active pharmaceutical ingredient; DLS; dynamic light scattering; EP; European Pharmacopoeia; FaSSGF; fasted state simulated gastric fluid; FaSSIF; fasted state simulated intestinal fluid; FaSSIF-V2; fasted state simulated int
Keywords: فارماکوپه اروپایی; 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
Validated high-performance anion-exchange chromatography with pulsed amperometric detection method for the determination of residual keratan sulfate and other glucosamine impurities in sodium chondroitin sulfate
Keywords: فارماکوپه اروپایی; CS(s); sodium chondroitin sulfate(s); Eur; European; EP; European Pharmacopoeia; GAG(s); glycosaminoglycan(s); Gal; galactose; GalN; galactosamine; GalNAc; N-acetylgalactosamine; GlcA; glucuronic acid; GlcN; glucosamine; GlcNAc; N-acetylglucosamine; HPAEC
Keywords: فارماکوپه اروپایی; Capillary zone electrophoresis; Protein composition; Immunoglobulins; Albumin; Human serum; European pharmacopoeia; Ac-Trp; N-acetyl tryptophan; Albumin-BRP2; Human albumin for electrophoresis BRP Batch 02; Albumin-BRP3; Human albumin for electrophoresis
Keywords: فارماکوپه اروپایی; API; Active Pharmaceutical Ingredient; EDQM; European Directorate for the Quality of Medicines and HealthCare; GMP; Good Manufacturing Practices; IPC; In Process Control; LF-NMR; Low-Field NMR spectroscopy; MEDS; Mission for Essential Drugs and Supplies;
Keywords: فارماکوپه اروپایی; AA; amino acid; AAA; amino acid analysis; APCI; atmospheric pressure chemical ionization; APPI; atmospheric pressure photo ionization; C4D; capacitively coupled contactless conductivity detector; CAD; corona charged aerosol detector; CBQCA; 3-(4-carboxybe
Keywords: فارماکوپه اروپایی; 2D-LC; two-dimensional liquid chromatography; AA; amino acid; AC; affinity chromatography; ADC; antibody-drug conjugates; ADCC; antibody-dependent cellular cytotoxicity; AF4; asymmetric flow field fractionation; APTS; 1-aminopyrene-3,6,8-trisulfonate; Asn
Keywords: فارماکوپه اروپایی; ACD; α-cyclodextrin, Alfadex; API; active pharmaceutical ingredient; BCD; β-cyclodextrin, Betadex; CAD; Charged Aerosol detector; CD; cyclodextrin; CTG; cyclodextrin transglycosylase; DBSA; bis(4-sulfobutyl) ether disodium; DIMEB; heptakis(2,6-di-O-meth
Keywords: فارماکوپه اروپایی; ACGIH; American Conference of Industrial Hygienists; AP; acidification potential; ATP; aquatic toxicity potential; ATPE; aqueous two-phase extraction; CIP; cleaning in place; CO; carbon oxides; CO2; carbon dioxide; EDTA; ethylenediaminetetraacetic acid; E
Keywords: فارماکوپه اروپایی; 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: فارماکوپه اروپایی; SUT; single-use technology; CMOs; contract manufacturing organisation(s); mAb; monoclonal antibody; BSL; biosafety level; CIP; cleaning-in-place; SIP; sterilisation-in-place; WFI; water for injection; DSP; downstream processing; CHO; Chinese hamster ovary
Keywords: فارماکوپه اروپایی; AFNOR; Association Française de Normalisation; AED; Atomic emission detector; ANRT; Association Nationale de la Recherche et de la Technologie; BS; British Standard; DSC; Differential scanning calorimetry; EFSA; European Food Safety Authority; EO; Essent
Keywords: فارماکوپه اروپایی; ADI; Acceptable Daily Intake; D; Decimal (1/10) homeopathic potency, Decimal Hahnemannian dilution; FSD; First Safe Dilution; GHP; German Homeopathic Pharmacopoeia; HMA; Heads of Medicines Agencies; HMPWG; Homeopathic Medicinal Products Working Group of H
Keywords: فارماکوپه اروپایی; EMA; European Medicines Agency; EDQM; European Directorate for the Quality of Medicines; MEB; Medicines Evaluation Board; SmPC; Summary of product characteristics; Ph. Eur.; European pharmacopoeia; KNMP; Koninklijke Nederlandse Maatschappij ter bevorderin
Keywords: فارماکوپه اروپایی; DCP; decentralised procedure; Eur. Com.; European Commission; EDQM; European Directorate for Quality of Medicines; EFTA; The European Free Trade Association; EMA; European Medicines Agency; EU; European Union; HMP; herbal medicinal product(s); HMPC; Commi
Keywords: فارماکوپه اروپایی; ManNAc-6-P; N-acetylmannosamine-6-phosphate; Glc; glucose; Gal; galactose; Neu5Ac; N-acetylneuraminic acid; HPAEC-PAD; high-pH anion-exchange chromatography with pulsed amperometric detection; PS-conj; polysaccharide-conjugate; TFA; trifluoroacetic acid;
A comparative study between outbred and inbred rat strains for the use in in vivo IPV potency testing
Keywords: فارماکوپه اروپایی; Inactivated poliovirus vaccine; Animal model; Sabin; Salk; Neutralizing antibodies; Immunogenicity; ELISA; enzyme-linked immunosorbent assay; EP; European Pharmacopoeia; GMT; geometric mean antibody titer; IPV; inactivated poliomyelitis vaccines; OPV; ora
Effects of a fixed herbal drug combination (Ze 185) to an experimental acute stress setting in healthy men - An explorative randomized placebo-controlled double-blind study
Keywords: فارماکوپه اروپایی; Valeriana officinalis; Passiflora incarnata; Petasites hybridus; Melissa officinalis; Cortisol; Anxiety; AE; Adverse Event; AUCI; Area Under the Curve with respect to increase; AUCG; Area Under the Curve with respect to ground; BMI; Body Mass Index; HMPC;
In-house cyclotron production of high-purity Tc-99m and Tc-99m radiopharmaceuticals
Keywords: فارماکوپه اروپایی; Technetium-99m; Cyclotron; Generator; Molybdenum-100; 99mTc-radiopharmaceuticals; Hospital radiopharmacy; SPECT; European Pharmacopoeia;
St John's wort (Hypericum perforatum) products - an assessment of their authenticity and quality
Keywords: فارماکوپه اروپایی; Quality control; Value chains,; Traditional Herbal Registration (THR); Avicularin/guaijaverin; St John's wort; Hypericum perforatum; ADC; automatic developing chamber; AV; avicularin; BRM; botanical reference material; DCHA; dicyclohexylamine; DCM; dichlo
In vitro models for immunogenicity prediction of therapeutic proteins
Keywords: فارماکوپه اروپایی; Therapeutic protein; Immunogenicity assessment; In vitro model; Subcutaneous injection; Injection site reactions; ADAs; antidrug antibodies; ALN; artificial lymph node; APCs; antigen presenting cells; ASCs; adipose-derived stem/stromal cells; DCs; dendrit
Nanopharmaceuticals for wound healing - Lost in translation?
Keywords: فارماکوپه اروپایی; Nanomaterials; Biomaterials; Advanced wound healing therapies; Current regulatory perspective; ASTM; American Society for Testing and Materials; CQA; critical quality attributes; ECM; extracellular matrix; EGF; epidermal growth factor; EMA; European medic
Testing of a palatable bait and compatible vaccine carrier for the oral vaccination of European badgers (Meles meles) against tuberculosis
Keywords: فارماکوپه اروپایی; HPO; hydrogenated (hardened) peanut oil; QC; quality control; PT; paste-bait; EP; European pharmacopoeia; USP; United States pharmacopoeia; IPA; iophenoxic acid; TAMC; total aerobic microbial count; TYMC; total yeast and mould count; Badger; BCG; Oral vac
Pre-registration efficacy study of a novel marker vaccine against classical swine fever on maternally derived antibody positive (MDA+) target animals
Keywords: فارماکوپه اروپایی; Classical swine fever; CSFV; Marker vaccine; MDA+; European pharmacopoeia; DIVA;
Impurity profiling of l-asparagine monohydrate by ion pair chromatography applying low wavelength UV detection
Keywords: فارماکوپه اروپایی; AA; amino acid; FMOC; 9-fluorenylmethyl chloroformate; ICH; International Council for Harmonization; LOQ; limit of quantitation; Ph. Eur.; European Pharmacopoeia; R2; regression coefficient; RSD; relative standard deviation; S/N; signal-to-noise ratio; RR
Establishment of chondroitin B lyase-based analytical methods for sensitive and quantitative detection of dermatan sulfate in heparin
Keywords: فارماکوپه اروپایی; 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
Development of fast dissolving oral films containing lercanidipine HCl nanoparticles in semicrystalline polymeric matrix for enhanced dissolution and ex vivo permeation
Keywords: فارماکوپه اروپایی; Ph.Eur.; European Pharmacopoeia; PEG 400; polyethylene glycol 400; TPGS 1000; d-alpha tocopheryl polyethylene glycol succinate 1000; PVA; polyvinyl alcohol; MC; methyl cellulose; HPC; hydroxypropyl cellulose; PDI; polydispersity index; HPLC; high-performa
Pre-registration efficacy study of a novel marker vaccine against classical swine fever on Maternally Derived Antibody negative (MDA-) target animals
Keywords: فارماکوپه اروپایی; Classical swine fever; Vaccine; Trial; European pharmacopoeia; Histopathology; DIVA;
Leonurus cardiaca L. herb extracts and their constituents promote lactoperoxidase activity
Keywords: فارماکوپه اروپایی; Bactericidal activity; Hypothiocyanite; Lactoperoxidase; Leonurus cardiaca L.; Caffeic acid derivatives; Caffeic acid (PubMed CID: 689043); Caffeoylmalic acid (PubMed CID: 6124299); Cichoric acid (PubMed CID: 5281764); Chlorogenic acid (PubMed CID: 179442
PBPK models for the prediction of in vivo performance of oral dosage forms
Keywords: فارماکوپه اروپایی; ABL; Aqueous Boundary Layer; BCS; Biopharmaceutics Classification System; BDDCS; Biopharmaceutical Drug Disposition Classification System; BE; Bioequivalence; CYP; Cytochrome P450; Peff; effective permeability; EP; European Pharmacopoeia; ER; Extended Rel
Characterisation and toxicological assessment of Neutral Methacrylate Copolymer for GRAS evaluation
Keywords: فارماکوپه اروپایی; BCA; bicinchoninic acid; bw; body weight; CAS; Chemical Abstract Service; DMEM; Dulbecco's Modified Eagle's Medium; DMF; drug master file; DMSO; dimethyl sulphoxide; DNFCS; Dutch National Food Consumption Survey; EA; ethyl acrylate; EC; European Counc
The standard mouse assay of anti-venom quality does not measure antibodies neutralising the haemorrhagic activity of Vipera ammodytes venom
Keywords: فارماکوپه اروپایی; Vipera ammodytes; Haemorrhagin; Ammodytoxin; Lethal toxicity assay; Lethal toxicity neutralisation; Antivenom; Atx; ammodytoxin; BSA; bovine serum albumin; ED50; median effective dose; ELISA; enzyme-linked immunosorbent assay; H; haemorrhagin; HRP; horse-
Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and
Keywords: فارماکوپه اروپایی; clinical trials; European Pharmacopoeia; Food and Drug Administration; good manufacturing practice; Mollicutes; mycoplasmas; acholeplasmas; quantitative polymerase chain reaction; tissue culture contaminants
A common standard is inappropriate for determining the potency of ultra low molecular weight heparins such as semuloparin and bemiparin
Keywords: فارماکوپه اروپایی; aPTT; activated partial thromboplastin time; ACT; activated clotting time; AT; antithrombin; EP; European Pharmacopoeia; HCII; heparin cofactor II; HIT; heparin-induced thrombocytopenia; LMWHs; low molecular weight heparins; NHP; normal human plasma; PPP;
Extraneous agents testing for substrates of avian origin and viral vaccines for poultry: Current provisions and proposals for future approaches
Keywords: فارماکوپه اروپایی; European Pharmacopoeia; Legislation; European Union; Extraneous agents testing
Evaluation of the sensitivity of PCR methods for the detection of extraneous agents and comparison with in vivo testing
Keywords: فارماکوپه اروپایی; Extraneous agents testing; PCR; ELISA; European Pharmacopoeia
Validation of a PCR method for the detection of mycoplasmas according to European Pharmacopoeia section 2.6.7
Keywords: فارماکوپه اروپایی; Mycoplasma; PCR method; Validation; Biosafety; European Pharmacopoeia
In vitro determination of tetanus toxicity by an endopeptidase assay linked to a ganglioside-binding step
Keywords: فارماکوپه اروپایی; Clostridial neurotoxins; Tetanus neurotoxin; In vitro; Endopeptidase assay; Binding assay; Synaptobrevin; Gangliosides; BoNT; botulinum neurotoxin; BSA; bovine serum albumin; EP; European Pharmacopoeia; H-chain; heavy chain; L-chain; light chain; Lf; limi
A validated capillary electrophoresis method to check for batch-to-batch consistency during recombinant human glycosylated interleukin-7 production campaigns
Keywords: فارماکوپه اروپایی; BGE; background electrolyte; CE; capillary electrophoresis; CHO; Chinese Hamster Ovary; CZE; capillary zone electrophoresis; DAB; diaminobutane; E. coli; Escherichia coli; EOF; electroosmotic flow; Eu. Ph.; European pharmacopoeia; ICH; International Confe
Development, standardization and assessment of PCR systems for purity testing of avian viral vaccines
Keywords: فارماکوپه اروپایی; Avian viral vaccines; Extraneous agent; European Pharmacopoeia; Polymerase chain reaction
Structural elucidation of the Rifaximin Ph. Eur. Impurity H
Keywords: فارماکوپه اروپایی; Rifaximin; 802 Dalton impurity; European Pharmacopoeia; Structural elucidation; HPLC/MS/MS; Spectroscopic techniques
Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins
Keywords: فارماکوپه اروپایی; Tetanus immunoglobulin; Potency assay; Batch control testing; Animal use replacement; European Pharmacopoeia;
A sampling and dilution system for droplet aerosols from medical nebulisers developed for use with an optical particle counter
Keywords: فارماکوپه اروپایی; HPLC; high performance liquid chromatography; NGI; Next Generation Impactor; OPC; optical particle counter; Ph. Eur.; European Pharmacopoeia; PSD; particle size distribution.; Nebuliser; Cascade impaction; Laser diffraction; Humidity conditioning; Light-s
Evaluation of the European Pharmacopoeia method for control of residual solvents in some antibiotics
Keywords: فارماکوپه اروپایی; Residual solvents; European Pharmacopoeia; Antibiotics; Headspace; GC
Development of an enhanced separation of erythromycin and its related substances by liquid chromatography
Keywords: فارماکوپه اروپایی; HPLC; Erythromycin; European Pharmacopoeia;
Contrôle de qualité des antibiotiques dans la Pharmacopée Européenne : évolution récente dans le cas des aminosides
Keywords: فارماکوپه اروپایی; Aminosides; Contrôle analytique; Pharmacopée européeenne; Détection; Chromatographie liquide haute performance; Aminoglycosides; Analytic quality control; European Pharmacopoeia; Detection; High-performance liquid chromatography;
Introduction of a validation concept for a PCR-based Mycoplasma detection assay
Keywords: فارماکوپه اروپایی; CCU; cell culture; European Pharmacopoeia; FDA; Mycoplasma; PCR; validation concept
Development and performance of a new hydrofluoroalkane (HFA 134a)-based metered dose inhaler (MDI) of salmeterol
Keywords: فارماکوپه اروپایی; Metered dose inhaler; Bronchodilator; Salmeterol; Hydrofluoroalkane HFA; Particle size distribution; Dose uniformity; BOU; beginning of use; CFC; chlorofluorocarbon; CPMP; Committee for Proprietary Medicinal Products; ECD; effective cut-off diameter; EOU;