Keywords: کنفرانس بین المللی هماهنگی; BBA; 4-(butylamino) benzoic acid; CP; cyclophosphamide; DMSO; dimethyl sulfoxide; HPBL; human peripheral blood lymphocytes; ICH; International Conference on Harmonization; MPCE; micronucleated polychromatic erythrocyte; MPG; methylated polyethylene glycol
مقالات ISI کنفرانس بین المللی هماهنگی (ترجمه نشده)
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Keywords: کنفرانس بین المللی هماهنگی; Biotherapeutics; Gene and cell therapy; Pharmacokinetics; Non-clinical safety; Immunogenicity; Cross-reactive species; ATMP; advanced therapy medicinal products; CAR; chimeric antigen receptor; CD; cluster of differentiation; CMC; chemistry manufacturing
Keywords: کنفرانس بین المللی هماهنگی; AA; Ascorbic acid; CD; Cyclodextrin; DS; Direct sunlight; EHMC; Ethylhexylmethoxycinnamate; FL; Fluorescent lamp; ICH; International Conference on Harmonization; HPML; High-pressure mercury lamp; NLC; Nanostructured lipid carriers; O/W; Oil-in-water; PBSA
Keywords: کنفرانس بین المللی هماهنگی; Quality; Transitivity; Traceability; Quality marker; Herbal medicinal product; AHP; The American Herbal Pharmacopoeia; BA; biopotency assay; BHP; The British Herbal Pharmacopoeia; CHM; Chinese herbal medicines; CMC; chemistry manufacturing controls; CMM;
Keywords: کنفرانس بین المللی هماهنگی; AD; atopic dermatitis; AUC24; area under the concentration-time curve from 0 to 24Â h; cAMP; cyclic adenosine monophosphate; CMC; carboxymethylcellulose; ECAC; Executive Carcinogen Advisory Committee; ICH; International Conference on Harmonization; IgE; i
Keywords: کنفرانس بین المللی هماهنگی; ANN; artificial neural networks; API; active pharmaceutical Ingredient; CFD; computational fluid dynamics; CMA; critical material attribute; CQA; critical quality attribute; CPP; critical process parameter; DEM; discrete element Method; DoDE; design of dy
Keywords: کنفرانس بین المللی هماهنگی; CFR; Code of Federal Regulations; COI; conflict of interest; FIH; first-in-human; GCP; good clinical practice; ICF; informed consent form; ICH; International Conference on Harmonization; IRB; institutional review board; TM; therapeutic misconception; TMis
Keywords: کنفرانس بین المللی هماهنگی; INERA; Institut National pour l'Etude et la Recherche Agronomiques; HPLC; high performance liquid chromatography; DAD; diode array detector; CRS; chemical reference substance; ICH; International Conference on Harmonization; ANOVA; analysis of variance; SD
Keywords: کنفرانس بین المللی هماهنگی; AFM; atomic force microscopy; BSA; bovine serum albumin; CD; circular dichroism; Cgâ²; maximal concentration of the cryoconcentrated solution; DSC; differential scanning calorimetry; ESCA; electron spectroscopy for chemical analysis; ESEM; environmental
Keywords: کنفرانس بین المللی هماهنگی; advanced therapy medicinal product; advanced therapy medicinal product with hospital exemption; genetically modified organism; market access; ADI; aid for development of innovation; AFM; French Association against Myopathies (Association Française contre
Keywords: کنفرانس بین المللی هماهنگی; CI; confidence interval; CP; cyclophosphamide; GLP; Good Laboratory Practices; HPLC; high performance liquid chromatography; HPTLC; high performance thin layer chromatography; ICH; International Conference on Harmonization; l.c.; label claim; LoD; limit o
Keywords: کنفرانس بین المللی هماهنگی; 2,4-D; 2,4-dichlorophenoxyacetic acid; ACD; allergic contact dermatitis; ACSA; agricultural chemical safety assessment; AFC; antibody forming cell; CP; cyclophosphamide; CT; carbon tetrachloride; DART; developmental and reproductive toxicology; DIT; devel
Keywords: کنفرانس بین المللی هماهنگی; AEFI; Adverse Event Following Immunization; CIOMS; Council for International Organizations of Medical Sciences; CRF; Case Report Form; CSP; Central Safety Physician; DSMB; Data and Safety Monitoring Board; FDA; United States Food and Drug Administration;
Isothermal chemical denaturation as a complementary tool to overcome limitations of thermal differential scanning fluorimetry in predicting physical stability of protein formulations
Keywords: کنفرانس بین المللی هماهنگی; µDSC; differential scanning microcalorimetry; Cm; concentration (in M) of chemical denaturant needed to unfold 50% of the protein (“melting” concentration of denaturant); dG; Gibbs free energy of unfolding; dHionisation; enthalpy of ionisation; dpH/d
Development of a non-toxic and non-denaturing formulation process for encapsulation of SDF-1α into PLGA/PEG-PLGA nanoparticles to achieve sustained release
Keywords: کنفرانس بین المللی هماهنگی; AFM; atomic force microscopy; BSA; bovine serum albumin; CXCR4; C-X-C chemokine receptor type 4; DL; drug loading; DMEM; Dulbecco's Modified Eagle's Medium; DMI; isosorbide dimethyl ether/dimethyl isosorbide; DMSO; dimethyl sulfoxide; EE; encapsulatio
In vitro secondary pharmacological profiling: An IQ-DruSafe industry survey on current practices
Keywords: کنفرانس بین المللی هماهنگی; AUC; Area Under the Curve; CRO; Contract Research Organization; CTA; Clinical Trial Authorization; GLP; Good Laboratory Practice; hERG; human ether-a-go-go-related gene; ICH; International Conference on Harmonization; IND; Investigational New Drug; IQ; In
Detection and quantification of phenethylamines in sports dietary supplements by NMR approach
Keywords: کنفرانس بین المللی هماهنگی; ACN; acetonitrile; CDCl3; deuterium chloroform; CIGAR-HMBC; constant time inverse-detected gradient accordion rescaled heteronuclear multiple-bond correlation; 1D; one dimension; 2D; two dimension; D2O; deuterium oxide; DSLD; Dietary Supplement Label Data
CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion
Keywords: کنفرانس بین المللی هماهنگی; Comprehensive In-Vitro Proarrhythmia assay; CiPA; hERG; Multiple cardiac ion channels; Proarrhythmia; QTc; Torsade de pointes; AV; atrioventricular; CiPA; Comprehensive In-Vitro Proarrhythmia Assay; CSRC; Cardiac Safety Research Consortium; DG; Discussion
Characterization of N-Acetyl-Tryptophan Degradation in Protein Therapeutic Formulations
Keywords: کنفرانس بین المللی هماهنگی; HPLC (high-performance/pressure liquid chromatography); oxidation; excipients; chemical stability; formulation; analytical chemistry; AAPH; 2,2â²-Azobis(2-amidinopropane) dihydrochloride; DiOia; dioxyindolylalanine; HSA; human serum albumin; ICH; Interna
Antifungal photosensitive activity of Porophyllum obscurum (Spreng.) DC.: Correlation of the chemical composition of the hexane extract with the bioactivity
Keywords: کنفرانس بین المللی هماهنگی; ACN; acetonitrile; AHP; American Herbal Pharmacopoeia; AMB; Amphotericin B; ANOVA; analysis of Variance; ATCC; American Type Culture Collection; CCC; CEREMIC culture collection; CEREMIC; Centro de Referencia de MicologÃa; CFU; colony-forming units; CLSI;
Effect of ambient light on IgG1 monoclonal antibodies during drug product processing and development
Keywords: کنفرانس بین المللی هماهنگی; ACN; acetonitrile; DTT; dithiothreitol; FS; fluorescence; His; l-Histidine; ICH; International Conference on Harmonization; mAb; monoclonal antibody; Met; l-Methionine; Phe; Phenylalanine; TFA; trifluoroacetic acid; Trp; l-Tryptophan; Tyr; l-Tyrosine; Pho
Comprehensive in vitro Proarrhythmia Assay (CiPA): Pending issues for successful validation and implementation
Keywords: کنفرانس بین المللی هماهنگی; Comprehensive in vitro Proarrhythmia Assay (CiPA); Field potential data sampling and analysis; Induced pluripotent cell cardiomyocytes (hiPSC-CMs); Multi electrode array (MEA); Patch clamp technologies; Pending issues and solutions; Validation; Voltage se
Development of fast dissolving oral films containing lercanidipine HCl nanoparticles in semicrystalline polymeric matrix for enhanced dissolution and ex vivo permeation
Keywords: کنفرانس بین المللی هماهنگی; 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
The Diplomate in Safety Pharmacology (DSP) certification scheme
Keywords: کنفرانس بین المللی هماهنگی; DSP; Diplomate in Safety Pharmacology; SP; safety pharmacology; SPS; Safety Pharmacology Society; JSPS; Japanese Safety Pharmacology Society; ICH; International Conference on Harmonization; SOT; Society of Toxicology; ACT; American College of Toxicology;
An FDA oncology analysis of antibody-drug conjugates
Keywords: کنفرانس بین المللی هماهنگی; AD; acceptable dose; ADC; antibody-drug conjugate; ADCC; antibody-dependent cellular cytotoxicity; FIH; first-in-human; HNSTD; highest non-severely toxic dose; ICH; International Conference on Harmonization; LC/MS; liquid chromatography/mass spectrometry;
New UHPLC-QqQ-MS/MS method for quantitative and qualitative determination of free phytoprostanes in foodstuffs of commercial olive and sunflower oils
Keywords: کنفرانس بین المللی هماهنگی; ALA; α-linolenic acid; AA; Arachidonic Acid; GC-MS; gas chromatography coupled to mass spectrometry; HPLC; high performance liquid chromatography; ICH; International Conference on Harmonization; LOD; limit of detection; LOQ; limit of quantification; MR
Dihomo-isoprostanes-nonenzymatic metabolites of AdA-are higher in epileptic patients compared to healthy individuals by a new ultrahigh pressure liquid chromatography-triple quadrupole-tandem mass spectrometry method
Keywords: کنفرانس بین المللی هماهنگی; OS; oxidative stress; OI; oxidative injury; IsoPs; isoprostanes; AA; arachidonic acid; NeuroPs; neuroprostanes; DHA; docosahexaenoic acid; DPA; docosapentanoic acid; Dihomo-IsoPs; dihomo-isoprostanes; AdA; adrenic acid; EIA; enzyme immunoassay; GC-MS; g
Preparation and characterization of micronized ellagic acid using antisolvent precipitation for oral delivery
Keywords: کنفرانس بین المللی هماهنگی; DLLSM; dynamic laser light scattering meter; DPPH; 2,2-diphenyl-1-picrylhydrazyl; DSC; differential scanning calorimetry; EA; ellagic acid; GC; gas chromatography; LC-MS/MS; liquid chromatography-tandem mass spectrometry; m-EA; micronized ellagic acid
Photostability and ex-vivo permeation studies on diclofenac in topical niosomal formulations
Keywords: کنفرانس بین المللی هماهنگی; DC; diclofenac; AA; ascorbic acid; NSAID; non steroidal anti-inflammatory drug; ICH; International Conference on Harmonization; MCR-ALS; multivariate curve resolution-alternating least squares; DLS; dynamic light scattering; TEM; transmission electron m
Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation
Keywords: کنفرانس بین المللی هماهنگی; API; active pharmaceutical ingredient; Cmax; maximum plasma concentration; CQA; critical quality attribute; CPP; critical process parameter; EMA; European Medicines Agency; FDA; Food and Drug Administration; HA; sodium hyaluronate; ICH; International Conf
Cryopreservation of human monocytes for pharmacopeial monocyte activation test
Keywords: کنفرانس بین المللی هماهنگی; 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
A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee
Keywords: کنفرانس بین المللی هماهنگی; ADRs; adverse drug reactions; CDER; Center for Drug Evaluation and Research; cTn; cardiac troponin; CV; cardiovascular; EMA; European Medicines Agency; EWG; Expert Working Group; ECG; electrocardiogram; HESI; Health and Environmental Sciences Institute; h
Single priming dose of meningococcal group C conjugate vaccine (NeisVac-C®) in infants
Keywords: کنفرانس بین المللی هماهنگی; AE; adverse event; CI; confidence interval; GCP; good clinical practice; GMT; geometric mean titer; ICH; International Conference on Harmonization; IU; international unit; MCC; meningococcal C conjugate vaccine; rSBA; serum bactericidal activity (using ra
Genotoxicity of pyrroloquinoline quinone (PQQ) disodium salt (BioPQQâ¢)
Keywords: کنفرانس بین المللی هماهنگی; 2AA; 2-aminoanthracene; AF-2; 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide; B[a]P; benzo[a]pyrene; bw; body weight; CHL; Chinese hamster lung; DMSO; dimethyl sulfoxide; GSH; glutathione; ICH; International Conference on Harmonization; ICR-191; -methoxy-6-ch
Evaluation of the genotoxicity of the food additive, gum ghatti
Keywords: کنفرانس بین المللی هماهنگی; CHO; Chinese hamster ovary; FDA; US Food and Drug Administration; GLP; Good Laboratory Practice; ICH; International Conference on Harmonization; JaCVAM; Japanese Center for the Validation of Alternative Methods; JECFA; Joint FAO/WHO Expert Committee on Fo
Establishing and analyzing the design space in the development of direct compression formulations by gene expression programming
Keywords: کنفرانس بین المللی هماهنگی; FDA; Food and Drug Administration; GMP; Good Manufacturing Practice; QbD; quality by design; ICH; International Conference on Harmonization; RSM; Response Surface Methodology; GEP; gene expression programming; MSE; Mean Squared Error; SRM; Structural Risk
Safety assessment of the commensal strain Bacteroides xylanisolvens DSM 23964
Keywords: کنفرانس بین المللی هماهنگی; BW; body weight; CFU; colony-forming unit; Crl; Charles River Laboratories; DMSO; dimethyl sulfoxide; EC; European Commission; FAO; Food and Agriculture Organization; FECI; Freiburg Ethics Commission International; GCP; Good Clinical Practice; GLP; Good L
Safety assessment of lutein and zeaxanthin (Lutemax⢠2020): Subchronic toxicity and mutagenicity studies
Keywords: کنفرانس بین المللی هماهنگی; ALP; alkaline phosphatase; ALT; alanine aminotransferase; AST; aspartate aminotransferase; FDA; food and drug administration; ICH; international conference on harmonization; NOAEL; no-observed-adverse-effect level; OECD; organization for economic co-opera
Safety assessment of a solid lipid curcumin particle preparation: Acute and subchronic toxicity studies
Keywords: کنفرانس بین المللی هماهنگی; ALP; alkaline phosphatase; ALT; alanine aminotransferase; AST; aspartate aminotransferase; FDA; food and drug administration; ICH; international conference on harmonization; NOAEL; no-observed-adverse-effect level; OECD; organization for economic co-opera
A validated capillary electrophoresis method to check for batch-to-batch consistency during recombinant human glycosylated interleukin-7 production campaigns
Keywords: کنفرانس بین المللی هماهنگی; 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
Effects of green tea catechin on embryo/fetal development in rats
Keywords: کنفرانس بین المللی هماهنگی; FDA; food and drug administration; GD; gestation day; GRAS; generally recognized as safe; GTC; green tea catechin; GTC-H; heat-sterilized green tea catechin; ICH; International Conference on Harmonization; MHLW; Ministry of Health Labour and Welfare; NOAE
If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?
Keywords: کنفرانس بین المللی هماهنگی; CHMP; Committee for Medicinal Products for Human Use; COX; Cycloxygenase; ECG; Electrocardiogram; EU; European Union; FDA; Food and Drug Administration of the United States; hERG; Human ether-a-go-go related gene; ICH; International Conference on Harmoniz
A comparative method of evaluating quality of international clinical studies in China: Analysis of site visit reports of the Clinical Research Operations and Monitoring Center
Keywords: کنفرانس بین المللی هماهنگی; Clinical trial; Clinical study; Good Clinical Practice; International Conference on Harmonization; Quality; China; HIV; AIDS;
Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A
Keywords: کنفرانس بین المللی هماهنگی; CNS; central nervous system; FDA; food and drug administration; GLP; good laboratory practice; GMP; good manufacturing practice; ICH; international conference on harmonization; IND; investigational new drug; NDA; new drug application; PMDA; pharmaceutical