Keywords: کنفرانس بین المللی هماهنگی; Bronchodilator agents; Electrocardiography; GFF MDI; Pulmonary disease; Chronic obstructive; Holter monitoring; QT prolongation; AE; adverse event; AV; atrioventricular; BID; twice daily; BMI; body mass index; bpm; beats per minute; CI; confidence interva
مقالات ISI کنفرانس بین المللی هماهنگی (ترجمه نشده)
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Keywords: کنفرانس بین المللی هماهنگی; Spray drying; Solid dispersion; Amorphous; Poorly soluble drugs; Formulation; AFM; Atomic force microscopy; ANN; Artificial neural networks; ANOVA; Analysis of variance; API; Active pharmaceutical ingredient; ASD; Amorphous solid dispersion; ATC; Atorvast
Keywords: کنفرانس بین المللی هماهنگی; robustness; quality by design; biopharmaceutical; drug product; formulation; manufacturing process; design space; BLA; biological license application; BPDG-FPS; Biophorum Development Group-Formulation Point Share; CQA; critical quality attribute; CPP; c
Comparability study of Rituximab originator and follow-on biopharmaceutical
Keywords: کنفرانس بین المللی هماهنگی; AA; amino acid; ABC; ammonium bicarbonate; ACN; acetonitrile; ADCC; antibody-dependent cellular cytotoxicity; CD; circular dichroism; CDC; complement-dependent cytotoxicity; CDRs; complementarity determining regions; CH; constant region of heavy chain; CH
Keywords: کنفرانس بین المللی هماهنگی; Food foam; Appetite; Satiety; Energy; Equivalence; AUC; area under the curve; AUCtreat; area under the curve for the treatment period; CI; confidence interval; DATEM; diacetyl tartaric acid ester of mono- and diglycerides; eVAS; electronic visual analogue
Keywords: کنفرانس بین المللی هماهنگی; 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: کنفرانس بین المللی هماهنگی; AAALAC; Association for Assessment and Accreditation of Laboratory Animal Care; ANCOVA; analysis of covariance; ANOVA; analysis of variance; CDSER; Center for Drug Safety Evaluation and Research; CI; confidence interval; DSI; Data Sciences International;
Keywords: کنفرانس بین المللی هماهنگی; API; active pharmaceutical ingredient; CBQCA; 3-(4-carboxybenzoyl)quinolone-2-carboxaldehyde; DMSO; dimethyl sulfoxide; DOE; design of experiments; EDQM; European Directorate for the Quality of Medicines & HealthCare; FLD; fluorescence detection; HP-β-CD
Keywords: کنفرانس بین المللی هماهنگی; α-GST; alpha-glutathione S-transferase; B2M; beta-2 microglobulin; BUN; blood urea nitrogen; CROs; contract research organisations; Cr; creatinine; CysC; cystatin C; DIKI; drug-induced kidney-injury; EFPIA; European Federation of Pharmaceutical Industrie
Keywords: کنفرانس بین المللی هماهنگی; ADE; acceptable daily exposure; EMA; European Medicines Agency; ICH; International Conference on Harmonisation; ISPE; International Society of Pharmaceutical Engineers; MAC; maximum allowable carryover; MRTD; maximum recommended therapeutic dose; NOEL; no
Keywords: کنفرانس بین المللی هماهنگی; ADRs; adverse drug reactions; AEs; adverse effects; BPM; breaths per minute; DRF; dose range finding; GI; gastrointestinal; ICH; International Conference on Harmonisation; MTD; maximum tolerated dose; MV; minute volume; NSAID; non-steroidal anti-inflammat
An evaluation of electronic cigarette formulations and aerosols for harmful and potentially harmful constituents (HPHCs) typically derived from combustion
Keywords: کنفرانس بین المللی هماهنگی; E-cigarette; E-liquid; ENDS; Combustion; Harmful and potentially harmful constituents; HPHC; 1-NA; 1-aminonaphthalene; 2-NA; 2-aminonaphthalene; 4-ABP; 4-aminobiphenyl; B[a]P; benzo[a]pyrene; CFP; Cambridge Filter Pad; CORESTA; Cooperation Centre for Scie
Extreme testing of undiluted e-cigarette aerosol in vitro using an Ames air-agar-interface technique
Keywords: کنفرانس بین المللی هماهنگی; 2NF; 2-nitrofluorene; NaN3; sodium azide; NQO; 4-nitroquinoline 1-oxide; AAI; air agar interface; AAN; 2-aminoanthracene; ICR-191; ICR-191 mutagen; ALI; air liquid interface; B[a]P; benzo[a]pyrene; CORESTA; Cooperation Centre for Scientific Research Relat
Advantages of a validated UPLC-MS/MS standard addition method for the quantification of A-type dimeric and trimeric proanthocyanidins in cranberry extracts in comparison with well-known quantification methods
Keywords: کنفرانس بین المللی هماهنگی; ANOVA; analysis of variance; DAD; diode array detection; DMAC; dimethylaminocinnamaldehyde; FA; formic acid; ICH; international conference on harmonisation; MRM; multiple reaction monitoring; PACs; proanthocyanidins; RSD; relative standard deviation; TQ;
In vitro models for immunogenicity prediction of therapeutic proteins
Keywords: کنفرانس بین المللی هماهنگی; 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
Finding synergies for 3Rs - Toxicokinetics and read-across: Report from an EPAA partners' Forum
Keywords: کنفرانس بین المللی هماهنگی; Physiologically-based kinetic (PBK) modelling; Hazard and risk assessment; Weight-of-evidence (WoE); Threshold of toxicological concern (TTC); In vitro to in vivo extrapolation (IVIVE); Integrated approach for testing and assessment (IATA); Absorption; Di
Provision of food and water in rodent whole body plethysmography safety pharmacology respiratory studies - Impact on animal welfare and data quality
Keywords: کنفرانس بین المللی هماهنگی; bpm; breaths per minute; ICH; International Conference on Harmonisation; p.o.; oral gavage administration; MV; minute volume; f; respiratory rate; S.E.M.; standard error of the mean; TV; tidal volume; WBP; whole body plethysmography; Food; Water; Whole-bo
Reverse phase HPLC method for detection and quantification of lupin seed γ-conglutin
Keywords: کنفرانس بین المللی هماهنگی; HPLC; high pressure liquid chromatography; TFA; trifluoroacetic acid; MS/MS; mass spectroscopy; SDS-PAGE; sodium dodecyl sulphate polyacrylamide gel electrophoresis; ELISA; enzyme-linked immunosorbent assay; MRM; multiple reaction monitoring; RP-HPLC; rev
Detection of ECG effects of (2R,4R)-monatin, a sweet flavored isomer of a component first identified in the root bark of the Sclerochitin ilicifolius plant
Keywords: کنفرانس بین المللی هماهنگی; (2R,4R)-Monatin; QT prolongation; QTc; TQT study; Food ingredient; ADME; absorption, distribution, metabolism, and elimination; AE; adverse event; Ae; amounts excreted; AUC0-inf; area under the plasma concentration-time curve to infinite time; AUC0-t; a
Serum antibody response to Moraxella catarrhalis proteins OMP CD, OppA, Msp22, Hag, and PilA2 after nasopharyngeal colonization and acute otitis media in children
Keywords: کنفرانس بین المللی هماهنگی; Mcat; Moraxella catarrhalis; AOM; acute otitis media; NP; nasopharyngeal; OP; oropharyngeal; OMP; outer membrane protein; Spn; Streptococcus pneumoniae; NTHi; non-typeable Haemophilus influenzae; OppA; oligopeptide permease A; Msp; Moraxella surface prote
Manufacturing process used to produce long-acting recombinant factor VIII Fc fusion protein
Keywords: کنفرانس بین المللی هماهنگی; rFVIIIFc; Human cell line; HEK 293H; Hemophilia A; Manufacturing; Recombinant; aPTT; activated partial thromboplastin time; α-Gal; galactose-α-1,3-galactose; BDD; B domain-deleted; FcRn; neonatal Fc receptor; FVIII; factor VIII; HC; heavy chain; HCP; ho
A randomized, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma
Keywords: کنفرانس بین المللی هماهنگی; Asthma; Fixed-dose combination; Muscarinic antagonist; Inhaled corticosteroid; Trough FEV1; Ae; amount of dose excreted unchanged in urine; AE; adverse event; ALT; alanine aminotransferase; AUC; area under the curve; BID; twice daily; bpm; beats per minut
Current practice in the diagnosis and management of IBD-associated anaemia and iron deficiency in Germany: The German AnaemIBD Study
Keywords: کنفرانس بین المللی هماهنگی; IBD; inflammatory bowel disease; UC; ulcerative colitis; CD; Crohn's disease; IC; indeterminate colitis; NIS; non-interventional study; ID; iron deficiency; IDA; iron deficiency anaemia; GPC; German Physician's Circular; CDAI; Crohn's Disease Activity Ind
Antisense oligonucleotides on neurobehavior, respiratory, and cardiovascular function, and hERG channel current studies
Keywords: کنفرانس بین المللی هماهنگی; ASO; Antisense Oligonucleotide; CNS; Central Nervous System; ECG; Electrocardiography; FOB; Functional Observatory Battery; GLP; Good Laboratory Practice; hERG; Human Ether-a-go-go related gene; ICH; International Conference on Harmonisation; IC50; The ha
Advancing toxicology in RiskMAPP: Setting ADEs based on the subsequent drug substance
Keywords: کنفرانس بین المللی هماهنگی; ADE; acceptable daily exposure; BW; body weight; DSA; first drug substance used in processing drug equipment; DSB; subsequent drug substance used in processing drug equipment; EMA; European Medicines Agency; ICH; International Conference on Harmonisation;
The effect of long term storage on tobacco smoke particulate matter in in vitro genotoxicity and cytotoxicity assays
Keywords: کنفرانس بین المللی هماهنگی; ANCOVA; analysis of covariance; BAT; British American Tobacco; COM; Committee on Mutagenicity; CORESTA; Cooperation Centre for Scientific Research Relative to Tobacco; DMSO; dimethyl sulfoxide; GLP; Good Laboratory Practice; GVP; gas vapour phase; IC50; t
Validation of the modified hemagglutination inhibition assay (mHAI), a robust and sensitive serological test for analysis of influenza virus-specific immune response
Keywords: کنفرانس بین المللی هماهنگی; CPE; cytopathic effect; GxP; GCP/GLP/GCLP; GCP; good clinical practise; GCLP; good clinical laboratory practise; GLP; good laboratory practise; GMT; geometric mean titre; HA; hemagglutination assay; HAI; hemagglutination inhibition assay; HAU; hemagglutin
Consumer inhalation exposure to formaldehyde from the use of personal care products/cosmetics
Keywords: کنفرانس بین المللی هماهنگی; CIR; US Cosmetic Ingredient Review; FA; formaldehyde; GLP; Good Laboratory Practise; ICH; International Conference on Harmonisation; LOD; limit of detection; LOQ; limit of quantification; PCP; personal care product(s)/cosmetic(s); SCCS; EU Scientific Comm
A new microwave-assisted extraction method for melatonin determination in rice grains
Keywords: کنفرانس بین المللی هماهنگی; Microwave-assisted extraction; Melatonin; HPLC-FD; Rice grains; ANOVA; Analysis Of Variance; AOAC; Association of Official Agricultural Chemists; CV; coefficient of variance; EACEA; Education, Audiovisual and Culture Executive Agency; EIA; Enzyme-Immuno
The use of a novel tobacco-substitute sheet and smoke dilution to reduce toxicant yields in cigarette smoke
Keywords: کنفرانس بین المللی هماهنگی; Smoke toxicants; Tobacco-substitute; Filter studies; Biomarkers; CA; cellulose acetate (filter); COHb; carboxyhaemoglobin; DC; dual carbon (filter); DMEM; Dulbecco's Modified Eagle's Medium; EU; European Union; FTC; (USA) Federal Trade Commission; IC5
Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors
Keywords: کنفرانس بین المللی هماهنگی; ADME; absorption, distribution, metabolism, and excretion; ADI; Acceptable Daily Intake; Colipa; the European Cosmetic Toiletry and Perfumery Association; CYPs; cytochrome P450s; DNEL; Derived No Effect Level; DG; Directorate General; ECHA; EU Chemicals A
Guidelines from the International Conference on Harmonisation (ICH)
Keywords: کنفرانس بین المللی هماهنگی; International Conference on Harmonisation; NMR spectroscopy; Specifications; Analytical validation; Impurities stability;