ReviewMolecular therapy. Methods & clinical development2018
Toxicology and Biodistribution: The Clinical Value of Animal Biodistribution Studies.
Review in Molecular therapy. Methods & clinical development, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed.
- Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin.BMC pharmacology & toxicology · 2021Trial
- A roadmap for supporting the development of advanced therapy medicinal products in a European framework.The Lancet regional health. Europe · 2026Review
- Gadolinium-Doped Iron Oxide Nanoparticles Enhance Radiosensitivity in Melanoma Models Associated with Metabolic Dysfunction.Pharmaceutics · 2026Article
- Anticancer, Antitumor, and Antioxidant Microbial Lipids: Mechanism of Action, Production, and Clinical Application.Oxidative medicine and cellular longevity · 2026Review
- Zinc oxide nanoparticles mitigate insulin resistance in a D-galactose-induced C57BL/6 mouse model.Frontiers in endocrinology · 2026Article
- From Genetic Engineering to Preclinical Safety: A Study on Recombinant Human Interferons.International journal of molecular sciences · 2025Article
- Divergent Delivery and Expression Kinetics of Lipid and Polymeric Nanoparticles across mRNA Modalities.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Characterization of the biodistribution profile of a human Dialyzable Leukocyte Extract (hDLE) byFrontiers in pharmacology · 2025Article
- A novel approach to quantitate biodistribution and transduction of adeno-associated virus gene therapy using radiolabeled AAV vectors in mice.Molecular therapy. Methods & clinical development · 2024Article
- Mitochondrial DNA as a target for analyzing the biodistribution of cell therapy products.Scientific reports · 2024Article
- Quantitative pharmacokinetic and biodistribution studies for fluorescent imaging agents.Biomedical optics express · 2024Article
- Pharmacokinetics and Biodistribution of Phages and their Current Applications in Antimicrobial Therapy.Advanced therapeutics · 2024Article
- Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.Handbook of experimental pharmacology · 2024Article
- Synthesis, Optical Properties, and In Vivo Biodistribution Performance of Polymethine Cyanine Fluorophores.ACS pharmacology & translational science · 2023Article
- Cholesterol Lowering Biotechnological Strategies: From Monoclonal Antibodies to Antisense Therapies. A Pre-Clinical Perspective Review.Cardiovascular drugs and therapy · 2023Review
- ROCKETS - a novel one-for-all toolbox for light sheet microscopy in drug discovery.Frontiers in immunology · 2023Article
- Pharmacokinetics and Tissue Distribution of Coumarins fromPlants (Basel, Switzerland) · 2022Article
- Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective.Frontiers in medicine · 2022Article
- Biodistribution of adeno-associated virus type 2 carrying multi-characteristic opsin in dogs following intravitreal injection.Journal of cellular and molecular medicine · 2021Article
- A method to improve quantitative radiotracing-based analysis of the in vivo biodistribution of drug carriers.Bioengineering & translational medicine · 2021Article
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
Since the human genome decoding, understanding and identification of genetic disturbances behind many diseases, including cancer, are intensively increasing. Scientific and technological advances in this area trigger the search for therapeutic (curative) approaches targeting the correction of gene disturbances. Gene therapy medicinal products (GTMPs) emerge in this context, bringing new challenges for their characterization. Compared to small molecules, biodistribution is fundamental to identifying target organs and anticipating safety and efficacy, may be integrated into safety and pharmacology studies, and may eventually be anticipated based on specificities of vectors and constructs. This review describes and discusses the requirements for nonclinical development and evaluation of GTMPs versus conventional ones and the needs and challenges of constructing nonclinical packages that assure GTMPs' human safety from early development, taking into consideration usefulness and/or limitations of many conventional, preclinical models. The experience gained in the European context is referenced.
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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.