Keywords: علم مقررات; Animal health; Food safety; Policy; Food production; Industry-academia collaboration; Regulatory science;
مقالات ISI علم مقررات (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: علم مقررات; protein formulation; protein aggregation; image analysis; regulatory science;
Keywords: علم مقررات; bioequivalence; pharmacokinetics; regulatory science; dissolution; mechanistic modeling; pharmacokinetic/pharmacodynamic (PK/PD) correlation;
Keywords: علم مقررات; Drug interaction; Botanical product; St. John's wort; Fruit juices; Regulatory science;
Keywords: علم مقررات; protein aggregation; image analysis; quality control; regulatory science; protein formulation;
Keywords: علم مقررات; Adolescent; Smoking; Regulatory science; Nicotine; Nicotine reduction;
Keywords: علم مقررات; bioequivalence; dose-response; glycoprotein; glycosylation; in vitro-in vivo correlations; pharmacokinetics; pharmacodynamics; structure-activity relationship; regulatory science;
Keywords: علم مقررات; Bioequivalence; Topical generic products; Regulatory science; IVPT; NIR; Patents;
Keywords: علم مقررات; Consumer science; Regulatory science; Health claims; Food; Regulation; Japan;
Keywords: علم مقررات; European Union; Horizon 2020; Environment and health research; Regulatory science;
Keywords: علم مقررات; Regulatory science; Translational science; Data science; Drug development and Alzheimer's disease; Data standards; Clinical trials; CDISC; Mild cognitive impairment; Biomarkers; Clinical outcome assessments; Therapeutic Area User Guide;
Keywords: علم مقررات; protein formulation; accelerated stability; protein aggregation; subvisible particles; immunogenicity; microflow imaging; image analysis; quality control; regulatory science;
Keywords: علم مقررات; Pharmaceutical manufacturing; Product quality; Emerging technologies; Innovation; Regulatory science
Keywords: علم مقررات; bioequivalence; bioavailability; Biopharmaceutics Classification System; dissolution; pharmacokinetics; regulatory science;
Keywords: علم مقررات; cardiovascular drug development; regulatory science; translational researchATC, Anatomical Therapeutic Chemical; CI, confidence interval; CNS, central nervous system; FDA, Food and Drug Administration; HR, hazard ratio; LDL, low-density lipoprotein; PCSK9
Keywords: علم مقررات; immune response; physicochemical properties; protein aggregation; proteins; regulatory science;
Keywords: علم مقررات; Theory of Sampling; TOS; Blend uniformity analysis (BUA); Variographic analysis; Measurement uncertainty; Sampling paradigm shift; Regulatory science; Quality control;
Keywords: علم مقررات; Bioinformatics; Regulatory bioinformatics; Drug safety; Food safety; Regulatory science; GCRSR; GSRS; Next-generation sequencing; Microbiome; Genomics;
Keywords: علم مقررات; Alzheimer's disease; regulatory science; biomarker; clinical evaluation;
Keywords: علم مقررات; Genomics; Regulatory science; Next generation sequencing;
Keywords: علم مقررات; Electronic cigarettes; e-Cigarettes; Nicotine delivery; Internet sales; Vaping; Regulatory science;
Keywords: علم مقررات; continuous bioprocessing; perfusion cell culture; continuous purification; integrated continuous biomanufacturing; cell culture; chromatography; separation science; biotechnology; regulatory science;
Keywords: علم مقررات; Therapeutic vaccine; Immunotherapy; Cancer; Regulatory science
Keywords: علم مقررات; trace elements; US FDA; trace metal; excipients; microwave-assisted digestion; ICP-MS; Analytical Chemistry; Global Health; Mass Spectrometry; Regulatory Science;
Keywords: علم مقررات; Autologous cell; Chondrocyte; Epithelial cell; Fibroblast; Macrophage; Regenerative medicine; Regulatory science; Tissue engineering
Keywords: علم مقررات; nanoparticles; controlled release; responsive delivery systems; regulatory science; physicochemical properties;
Keywords: علم مقررات; drug interactions; absorption; protein binding; regulatory science; drug development; drug transporters;
Keywords: علم مقررات; Regulatory science; Regulatory agencies; Global Summit on Regulatory Science;
Keywords: علم مقررات; Nicotine; Tobacco; Cigarettes; Addiction; Harm reduction; Regulatory science
Keywords: علم مقررات; abnormal toxicity test; analysis; biotechnology; general safety; innocuity test; pharmacopoeia; quality control; regulatory science; toxicity; vaccines;
Keywords: علم مقررات; study design; inhaled corticosteroids; intranasal corticosteroids; hypothalamic-pituitary-adrenal (HPA) axis; pulmonary; regulatory science; pharmacodynamics; toxicity; pediatrics;
Keywords: علم مقررات; Regulatory science; Drug development; Benefit-risk assessment; Market authorization; Post-marketing surveillance;
An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment
Keywords: علم مقررات; analytical chemistry; excipients; formulation; mass spectrometry; regulatory science;
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride
Keywords: علم مقررات; proguanil hydrochloride; absorption; bioequivalence; Biopharmaceutics Classification System (BCS); excipients; permeability; regulatory science; solubility;
Regulatory-accepted drug development tools are needed to accelerate innovative CNS disease treatments
Keywords: علم مقررات; ACR; American College of Radiology; AD; Alzheimer disease; ADNI; Alzheimer's Disease Neuroimaging Initiative; ALS; Amyotrophic Lateral Sclerosis; ASD; Autism Spectrum Disorder; BBB; Blood-Brain-Barrier; BEST; Biomarkers, Endpoints and other Tools; BLA; Bi
Six years after the NRC review of EPA's Draft IRIS Toxicological Review of Formaldehyde: Regulatory implications of new science in evaluating formaldehyde leukemogenicity
Keywords: علم مقررات; Regulatory science; Hazard evaluation; Evidence integration; Epidemiology; Toxicology; Mechanistic studies;
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril
Keywords: علم مقررات; enalapril maleate; enalaprilat; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility; in situ conversion;
Liver-selective distribution in rats supports the importance of active uptake into the liver via organic anion transporting polypeptides (OATPs) in humans
Keywords: علم مقررات; Organic anion transporting polypeptide; Drug interaction; Hepatic uptake; Tissue distribution; Regulatory science
Effects of MAO inhibition and a combination of minor alkaloids, β-carbolines, and acetaldehyde on nicotine self-administration in adult male rats
Keywords: علم مقررات; Non-nicotine tobacco constituents; Nicotine; Monoamine oxidase inhibition; Tobacco policy; Self-administration; Regulatory science;
The Impact of the EMA Change in Definition of “Dose” on the BCS Dose-Solubility Ratio: A Review of the Biowaiver Monographs
Keywords: علم مقررات; biopharmaceutics classification system (BCS); bioavailability; bioequivalence; regulatory science;
Nanotherapeutics-Product Development Along the “Nanomaterial” Discussion
Keywords: علم مقررات; nanotechnology; materials science; drug delivery systems; regulatory science; EMA; US FDA; toxicity; nanoparticles; regulations; government; ADME, absorption distribution metabolism elimination; AFM, atomic force microscopy; AUC, analytical ultracentrifug
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam
Keywords: علم مقررات; piroxicam; absorption; biopharmaceutics classification system (BCS); permeability; solubility; dissolution; regulatory science;
The risk-based approach to ATMP development - Generally accepted by regulators but infrequently used by companies
Keywords: علم مقررات; Advanced therapy medicinal products; Risk-based approach; Scientific advice; Science-driven non-clinical drug development; Regulatory science;
Impact of Study Design on the Evaluation of Inhaled and Intranasal Corticosteroids' Effect on Hypothalamic-Pituitary-Adrenal Axis Function, Part I: General Overview of HPA Axis Study Design
Keywords: علم مقررات; pulmonary; regulatory science; pharmacodynamics; study design; inhaled corticosteroids; intranasal corticosteroids; hypothalamic-pituitary-adrenal axis;
Exploring the Relationships Between Scaled Bioequivalence Limits and Within-Subject Variability
Keywords: علم مقررات; bioequivalence; bioavailability; scaled limits; highly variable drugs; European Medicines Agency; Food and Drug Administration; mathematical models; regulatory science; pharmacokinetics; relative change;
The rise and fall of photomutagenesis
Keywords: علم مقررات; Photomutagenesis; Phototoxicity; Photoactivation; Regulatory science; UVB; IWGTP
Determination of Time to Onset and Rate of Action of Insulin Products: Importance and New Approaches
Keywords: علم مقررات; insulin; comparability; absorption; time to onset of action; rate of action; regulatory science; pharmacokinetics; pharmacodynamics; bioequivalence;
Parameter-finding studies of photodynamic therapy for approval in Japan and the USA
Keywords: علم مقررات; Photodynamic therapy; Regulatory science; Therapeutic parameter
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Efavirenz
Keywords: علم مقررات; efavirenz; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;
A Proposal for a Quality System for Herbal Products
Keywords: علم مقررات; process analytical technology; quality by design; biopharmaceuticals characterization; spectroscopy; regulatory science; bioanalysis; traditional medicine; herbal products; critical control point; Gingko biloba;