Keywords: مواد مخدر; Drug substance; Impurities; Threshold of toxicological concern (TTC); Acceptable intake (AI); Permissible daily exposure (PDE); Compound-specific limit; Class-specific limit; Monofunctional alkyl bromides;
مقالات ISI مواد مخدر (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: مواد مخدر; Dimethyl sulfoxide; Acetonitrile; Circular dichroism; Dissolution; Drug substance;
Keywords: مواد مخدر; Surface sampling; PDE; skin absorption; Drug substance; Occupational health;
Keywords: مواد مخدر; Stability study; Stress testing; Stability indicating methods; Drug substance; Drug products;
One single, fast and robust capillary electrophoresis method for the direct quantification of intact adenovirus particles in upstream and downstream processing samples
Keywords: مواد مخدر; Ad26; adenovirus serotype 26; Ad35; adenovirus serotype 35; Ad5; adenovirus serotype 5; AEX; anion exchange product; AEX-HPLC; anion exchange HPLC; AQbD; analytical quality by design; ATP; analytical target profile; CH; clarified harvest; CR; crude harves
Keywords: مواد مخدر; Impurities; ICH Q3; Analytical techniques; Drug substance; Drug product;
Keywords: مواد مخدر; Brx; Bioreactor; ATF; Alternating tangential filtration; CAPEX; Capital expenditure; DS; Drug substance; OPEX; Operational expenditure; SMB; Simulating moving bed; ATPS; Aqueous two phase systems; PCC; Periodic counter-current chromatography; mAb; Monoclo
Keywords: مواد مخدر; Matrix interference; Toxic impurity analysis; Matrix precipitation; Drug substance
Keywords: مواد مخدر; upstream; downstream; drug substance; drug product; mixing; solution; dispersion; heterogeneous; homogeneous;
Keywords: مواد مخدر; drug substance; continuous manufacturing; synthetic methods; crystallization; PAT; quality; safety; skills;
Keywords: مواد مخدر; Therapeutic salt; Pharmaceutical cocrystal; Amino acids; Active pharmaceutical ingredient (API); Drug substance; Coformer; Patent rights;
Bivalent rLP2086 (Trumenba®): Development of a well-characterized vaccine through commercialization
Keywords: مواد مخدر; DOE; design of experiments; DS; drug substance; ELISA; enzyme-linked immunosorbent assay; FDA; US Food and Drug Administration; FHbp; factor H binding protein; HCP; host cell proteins; NmB; Neisseria meningitidis serogroup B; Nm; Neisseria meningitidis; R
Enantioselective analysis for L-pidolic acid in ertugliflozin drug substance and drug product by chiral gas chromatography with derivatization
Keywords: مواد مخدر; Pidolic acid; Enantiomeric purity; Enantioselective gas chromatography; Validation; Derivatization; Drug substance; Drug product;
An in vitro cell-based potency assay for pharmaceutical type A botulinum antitoxins
Keywords: مواد مخدر; BoNT; botulinum neurotoxin; SNAREs; soluble N-ethylmaleimide-sensitive factor attachment protein receptors; SNAP-25; 25 kDa synaptosomal associated protein; WHO; World Health Organization; MsLD50; mouse 50% lethal dose; IIBR; Israel Institute for Biologic
Quantitative analysis of a biopharmaceutical protein in cell culture samples using automated capillary electrophoresis (CE) western blot
Keywords: مواد مخدر; CE; capillary electrophoresis; DS; drug substance; DTT; dithiothreitol; HMWI; high molecular weight isoform; HRP; horseradish peroxidase; RSD; relative standard deviation; SDS-PAGE; sodium dodecyl sulfate polyacrylamide gel electrophoresis; Automated west
Formulation development of SYN-004 (ribaxamase) oral solid dosage form, a β-lactamase to prevent intravenous antibiotic-associated dysbiosis of the colon
Keywords: مواد مخدر; AAD; antibiotic-associated diarrhea; CDAD; Clostridium difficile associated diarrhea; DP; drug product; DS; drug substance; GMS; glycerol monostearate; HPC; hydroxypropyl cellulose; HPMC; hydroxypropyl methylcellulose; IIG; inactive ingredient guide; PS80
A new method to identify hydrolytic degradants in drug substances with UPLC-MS using 18O-labelled water
Keywords: مواد مخدر; Drug substance; Degradation; Hydrolysis; UPLC-MS; H2O18
Effect of channel-induced shear on biologics during ultrafiltration/diafiltration (UF/DF)
Keywords: مواد مخدر; Ultrafiltration/diafiltration; Cassette feed screens; Shear; Biologic; Drug substance; Product quality
Determination of (R)-timolol in (S)-timolol maleate active pharmaceutical ingredient: Validation of a new supercritical fluid chromatography method with an established normal phase liquid chromatography method
Keywords: مواد مخدر; Supercritical fluid chromatography; Drug substance; R-timolol impurity limit test; Method validation; Timolol maleate
Stability of sample solution as a crucial point during HPLC determination of chemical purity of temozolomide drug substance
Keywords: مواد مخدر; Temozolomide; HPLC; Stability; Drug substance; Mathematical correction;
Establishment of cocrystal cocktail grinding method for rational screening of pharmaceutical cocrystals
Keywords: مواد مخدر; CC, cocrystal; CCF, cocrystal former; API, active pharmaceutical ingredient; PXRD, powder X-ray diffraction; TG, thermogravimetry; DSC, differential scanning calorimetryCocrystal; Grinding; Drug substance; Amorphous; Crystallinity; Physicochemistry
Interdependence of Drug Substance Physical Properties and Corresponding Quality Control Strategy
Keywords: مواد مخدر; physical property; particle size; drug substance; design space; quality by design; dissolution; multivariate analysis; principle component analysis; solid dosage form; physical characterization;
Comparability studies of new 3rd generation recombinant human factor VIII GreenGene F after improvement of formulation and viral inactivation/removal process
Keywords: مواد مخدر; B-Domain deleted recombinant factor VIII; GreenGene F; Homogeneous FVIII; Comparability; Viral inactivation; Protein characteristics; FVIII; human factor VIII; rFVIII; recombinant FVIII; S/D; solvent/detergent; BDD-rFVIII; B-domain deleted recombinant fac
Applications of cathodoluminescence spectroscopy and imaging in the characterisation of pharmaceutical materials
Keywords: مواد مخدر; Cathodoluminescence; Scanning electron microscopy; API; Drug substance; Drug product; Organic compounds
Effect of incomplete removal of the tert-butoxycarbonyl protecting group during synthesis of a pharmaceutical drug substance on the residual solvent analysis
Keywords: مواد مخدر; Headspace-GC; Residual solvent analysis; Isobutylene; tert-Butoxycarbonyl (BOC) protection; Drug substance
Matrix deactivation: A general approach to improve stability of unstable and reactive pharmaceutical genotoxic impurities for trace analysis
Keywords: مواد مخدر; Matrix deactivation; Genotoxic impurity; Drug substance; Solution stability; Trace analysis
A generic static headspace gas chromatography method for determination of residual solvents in drug substance
Keywords: مواد مخدر; Headspace gas chromatography; Residual solvents; Drug substance; Method validation
A generic approach for the determination of trace hydrazine in drug substances using in situ derivatization-headspace GC–MS
Keywords: مواد مخدر; Hydrazine; Genotoxic impurity; Drug substance; Headspace; GC–MS
Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance
Keywords: مواد مخدر; Genotoxic; Impurities; Mixtures; Drug substance
Is HPLC assay for drug substance a useful quality control attribute?
Keywords: مواد مخدر; HPLC assay; Drug substance; Assay variability; Out-of-specification; Precision
Assuring quality of drugs by monitoring impurities
Keywords: مواد مخدر; Characterization; Chiral impurity; Degradation product; Drug product; Drug substance; Isolation; Profiling; Selective analytical methodologies; Terbutaline
Pharmaceutical impurities: Regulatory perspective for Abbreviated New Drug Applications
Keywords: مواد مخدر; Impurity; Drug substance; Drug product; Abbreviated New Drug Applications (ANDAs)
Strategies for the investigation and control of process-related impurities in drug substances
Keywords: مواد مخدر; Process impurities; Related substances; Drug substance; Active pharmaceutical ingredient; Chiral; Orthogonal; Genotoxic impurity; Starting material; Formaldehyde; Sulfonate ester
Determination of desloratadine in drug substance and pharmaceutical preparations by liquid chromatography
Keywords: مواد مخدر; Desloratadine; Liquid chromatography; Drug substance; Pharmaceutical preparations;
Precision from drug stability studies
Keywords: مواد مخدر; Drug product; Drug substance; Analytical variability; Reproducibility; Analysis of variances; Regression;