Year of publication
Type of media
Subject
Type of material
Licence
Language
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Plant-derived exosomes: a green approach for cancer drug delivery
Royal Society of Chemistry | 2024|limitations of traditional drug delivery tools. Extraction of PDEs from plant sources employ diverse methodologies, encompassing ultracentrifugation ...Publisher: The Royal Society of Chemistry -
TARC and Septin 7 can be better monitoring biomarkers than CX3CL1, sICAM5, and IRF5 in children with seizure-free epilepsy with monotherapy and drug-resistant epilepsy
Taylor & Francis Verlag | 2024|levels of thymus activation-regulated chemokine (TARC), and interferon regulatory factor 5 (IRF5) in healthy controls, patients with epilepsy on ... -
Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies
Wiley | 2024|limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine ...Keywords: drug safety -
Forsythiaside A exhibits anti‐migration and anti‐inflammation effects in rheumatoid arthritis in vitro model
Wiley | 2024|regulatory roles in the treatment of RA. Forsythiaside A (FA) as an active ingredient isolated from forsythia suspensa has been discovered to ... -
Quality assessment of LNP-RNA therapeutics with orthogonal analytical techniques
Elsevier | 2024|Abstract The availability of analytical methods for the characterization ...Keywords: Food and Drug Administration, interferon regulatory factor, International Organization for Standardization -
Can I trust my fake data – A comprehensive quality assessment framework for synthetic tabular data in healthcare
Elsevier | 2024|Keywords: Analysis of variance F-test, Cancer Registry of Norway, the U.S. Food and Drug Administration, The International Medical Device Regulators Forum, Mean absolute error for means and standard deviations of columns, Precision in Estimation of Heterogeneous Effect (PEHE)), Predicted residual sum of squares -
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US
Taylor & Francis Verlag | 2023|The regulatory standards of the United States Food and Drug Administration (FDA) require substantial
... -
The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study
Wiley | 2023|the drug labels and reviewing documents disclosed on the official websites of the US Food and Drug Administration (FDA) and the Center for ...Keywords: regulatory approval -
The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020
Wiley | 2023|Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase
...Keywords: drug approval, quality of life -
Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure–Response
Wiley | 2023|extrapolation of adult efficacy data to children when the disease and drug effects are sufficiently similar. This study explored whether the ...Keywords: pharmacokinetics and drug metabolism, regulatory/scientific affairs -
CD25: A potential tumor therapeutic target
Wiley | 2023|CD25 is the alpha‐chain of the heterotrimer IL‐2 receptor. CD25 is expressed on the surface of both immune and
...Keywords: regulatory T cells -
Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness
Wiley | 2023|Research ethics committees and regulatory agencies assess whether the benefits of a proposed early‐stage
Keywords: regulatory science -
GABAergic neurons maturation is regulated by a delicate network
Wiley | 2023|engaged during the development of GABAergic neurons with the goal of exploring regulatory mechanisms that influence GABAergic neuron fate (i.e ... -
The WHO abortion care guideline: Law and policy—Past, present, and future
Wiley | 2023|models, drug regulation and the supply of abortion pills, and protective interventions crafted in the context of political crisis and immediate ... -
Purification processes of polymeric nanoparticles: How to improve their clinical translation?
Elsevier | 2023|to the economical, material and productivity considerations. In the meantime, we advocate the use of a harmonized international regulatory ...Keywords: Food and Drug Administration, Nano Drug Delivery Systems -
Patient safety classifications, taxonomies and ontologies, part 2: A systematic review on content coverage
Elsevier | 2023|Keywords: International Classification of Patient Safety, Danish adaptation of the ICPS, Ontology of Adverse Events, Modified- International Classification of patient safety, National Coordinating Council for Medication Error Reporting and Prevention Taxonomy of Medication Errors, Medical Dictionary for Regulatory Activities, Extended National Coordinating Council for Medication Error Reporting and Prevention Taxonomy of Medication Errors, Side Effects of Drugs Annual (SEDA) Classification of Adverse Drug Reactions, Adverse Drug Event Ontology, Classification of Causes of Drug-Related Problems, Adverse Drug Reaction Classification System, Ontology of Drug Adverse Events, Pharmaceutical Care Network Europe (PCNE) Drug-Related Problem Classification- German version, Adverse Drug Reaction Ontology, Classification of Intraoperative adverse events, Classification of Intraoperative adverse events- Extended, Food and Drug Administration (FDA) Adverse Event Problem Codes, Classification of Adverse Events with the DaVinci, Classification of Technology-induced Errors, Classification of Medical Errors and Preventable Adverse Events in Primary Care, Taxonomy of Patient Safety in General Practice, Taxonomy of Australian Patient Safety, Ontology of Adverse Drug Reactions for Automated Signal generation, Ontology for Automatic characterization of Adverse Drug Effects, Taxonomy of Medical Errors in Family Practice, Canadian Taxonomy of Errors and Adverse events for Family medicine, Cardiac Adverse Drug Event Ontology, Ontology of Cardiovascular Drug Adverse Events, System of Interventional Radiology Adverse Event Classification, Ontology of Clinical Communication for Medical Errors, Disease-Specific Ontology of Adverse Events, Emergency Department (ED) Taxonomy of AEs and Near misses, Taxonomy System for Analysis of Hemodialysis Incidents, Ontology of Drug Neuropathy Adverse Events, Taxonomy of Adverse Handover Events, Common Taxonomy of Ventilator-Related Adverse Events -
Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care
Online Contents | 2022|evidence. Main Measures Principal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA ...Publisher: Springer International Publishing, Springer, New York, NY -
Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States
Wiley | 2022|and Drug Administration approval. A harmonised, evidence‐based regulatory framework is needed to ensure approvals of needed, safe and ...Keywords: international comparison -
Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system
Online Contents | 2022|Background Previous reports on daptomycin’s adverse drug reactions (ADRs) have been insufficient, often because of limited data ...Publisher: Springer International Publishing, Springer, Dordrecht [u.a.]Keywords: Adverse drug reactions -
Orthogonal and complementary measurements of properties of drug products containing nanomaterials
Elsevier | 2022|presented, with a focus on measurement of physical properties of nano-enabled drug products, including liposomes and polymeric nanoparticles for ...Keywords: Food and Drug Administration, Guide to the Expression of Uncertainty in Measurement, National Institute of Standards and Technology, geometric radius or radius of gyration
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