ArticleCurrent research in toxicology2024
Visible particles in parenteral drug products: A review of current safety assessment practice.
Article in Current research in toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed.
- Electrostatic Interactions Guide the Detrimental Effect of Oleic Acid on Monoclonal Antibody Stability.Pharmaceutical research · 2026Article
- Optical imaging and spectroscopic characterization of subvisible particles in protein therapeutics.Advanced drug delivery reviews · 2026Review
- Machine Learning-Enabled Image Comparability Assessment for Flow Imaging Microscopy Across Platforms.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Science-Based Risk Assessment for the Categorization of Visual Inspection Defects of Sterile Dosage Forms.Pharmaceutics · 2025Article
- Micro-Flow Imaging: Enhanced Precision in Clarity Assessment of Traditional Chinese Medicine TCM Injections Compared to Light Obscuration and Visual Inspection.AAPS PharmSciTech · 2025Article
- Use of Factorial Designs to Reduce Stability Studies for Parenteral Drug Products: Determination of Factor Effects via Accelerated Stability Data Analysis.Pharmaceutics · 2025Article
- Submicron-sized superantigen biomimetic liposomes with highly efficient pulmonary accumulation to remodel local immune microenvironment for cancer chemoimmunotherapy.Acta pharmaceutica Sinica. B · 2025Article
- Production of Hydrophobic Microparticles at Safe-To-Inject Sizes for Intravascular Administration.Pharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Parenteral drug products (PDPs) are administered extensively to treat various diseases. Product quality plays a critical role in ensuring patient safety and product efficacy. One important quality challenge is the contamination of particles in PDPs. Particle presence in PDPs represents potential safety risk to patients. Differential guidance and practice have been in place for visible (VPs) and subvisible particles (SVPs) in PDPs. For SVPs, the amount limits have been harmonized in multiple Pharmacopeias. The pharmaceutical industry follows the guided limits for regulatory and quality compliance. However, for VPs, no such acceptable limit has been set. This results in not only quality but also safety challenges for manufacturers and drug developers in managing and evaluating VPs. It is important to understand the potential safety risk of VPs so these can be weighed against the benefit of the PDPs. To evaluate their potential risk(s), it is necessary to understand their nature, origin, frequency of their occurrence, safety risk, the risk mitigation measures, and the method to evaluate their safety. The current paper reviews the critical literature on these aspects and provides insight into considerations when performing safety assessment and managing the risk(s) for VPs in PDPs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.