ReviewMolecular biotechnology2004
Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges.
Review in Molecular biotechnology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- Emerging Gene Therapy Based on Nanocarriers: A Promising Therapeutic Alternative for Cardiovascular Diseases and a Novel Strategy in Valvular Heart Disease.International journal of molecular sciences · 2025Review
- Albumin Nanostructures for Nucleic Acid Delivery in Cancer: Current Trend, Emerging Issues, and Possible Solutions.Cancers · 2021Review
- Hurdles to uptake of mesenchymal stem cells and their progenitors in therapeutic products.The Biochemical journal · 2020Review
- Adverse immunostimulation caused by impurities: The dark side of biopharmaceuticals.British journal of clinical pharmacology · 2019Review
- Precise Personalized Medicine in Gynecology Cancer and Infertility.Frontiers in cell and developmental biology · 2019Review
- Thioacetamide-induced hepatic fibrosis in the common marmoset.Experimental animals · 2018Article
- Targeted nanoparticles for colorectal cancer.Nanomedicine (London, England) · 2016Review
- Cancer nanotechnology: the impact of passive and active targeting in the era of modern cancer biology.Advanced drug delivery reviews · 2014Review
- Targeted polymeric therapeutic nanoparticles: design, development and clinical translation.Chemical Society reviews · 2012Review
- Theranostic applications of nanomaterials in cancer: drug delivery, image-guided therapy, and multifunctional platforms.Applied biochemistry and biotechnology · 2011Review
- Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase.Drug safety · 2010Article
- Pharmacovigilance of biopharmaceuticals: challenges remain.Drug safety · 2009Review
- Biofunctionalized targeted nanoparticles for therapeutic applications.Expert opinion on biological therapy · 2008Review
- Review
- Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies.mAbsReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The unique and complex nature of biotechnology-derived pharmaceuticals has meant that it is often not possible to follow the conventional safety testing programs used for chemicals, and hence they are evaluated on a case-by-case basis. Nonclinical safety testing programs must be rationally designed with a strong scientific understanding of the product, including its method of manufacture, purity, sequence, structure, species specificity, pharmacological and immunological effects, and intended clinical use. This knowledge, coupled with a firm understanding of the regulatory requirements for particular product types, will ensure that the most sensitive and regulatory-compliant test systems are used to optimize the chances of gaining regulatory approval for clinical testing or marketing authorization in the shortest possible time frame.
Indexed as
Identifiers
15122047What OpenQuestion holds
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.