ArticlemAbs
Preclinical development of monoclonal antibodies: considerations for the use of non-human primates.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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
22 citing papers in PubMed.
- FDA roadmap to reducing animal testing: a regulatory and scientific paradigm shift in nonclinical safety assessment.Stem cell research & therapy · 2026Article
- Integrating Human Intestinal Organoids into FDA's New Approach Methodologies for Drug Discovery.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Article
- Laboratory-Scale Production of Recombinant IgG Antibodies.Methods in molecular biology (Clifton, N.J.) · 2026Article
- AI-Enabled Reduction of Animal Use in Cardiovascular Translational Medicine: Regulatory and Technological Perspectives.Life (Basel, Switzerland) · 2025Review
- Establishment of a humanized mouse model of pulmonary fibrosis for advancing drug validation strategies.Scientific reports · 2025Article
- GNUV201, a novel human/mouse cross-reactive and low pH-selective anti-PD-1 monoclonal antibody for cancer immunotherapy.BMC immunology · 2024Article
- A comparative study on intraocular pressure under various anesthetics in cynomolgus monkeys (Macaca fascicularis).Laboratory animal research · 2021Article
- Humanized Mouse as a Tool to Predict Immunotoxicity of Human Biologics.Frontiers in immunology · 2020Article
- Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture.Biotechnology progress · 2017Article
- Article
- Opportunities to Apply the 3Rs in Safety Assessment Programs.ILAR journal · 2016Article
- Assessing kinetic and epitopic diversity across orthogonal monoclonal antibody generation platforms.mAbs · 2016Article
- Review
- Pioneering better science through the 3Rs: an introduction to the national centre for the replacement, refinement, and reduction of animals in research (NC3Rs).Journal of the American Association for Laboratory Animal Science : JAALAS · 2015Article
- Challenges and approaches for the development of safer immunomodulatory biologics.Nature reviews. Drug discovery · 2013Review
- On the emerging role of rabbit as human disease model and the instrumental role of novel transgenic tools.Transgenic research · 2012Review
- The airways, a novel route for delivering monoclonal antibodies to treat lung tumors.Pharmaceutical research · 2011Article
- Ethics of primate use.Advances in science and research · 2010Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of mAbs remains high on the therapeutic agenda for the majority of pharmaceutical and biotechnology companies. Often, the only relevant species for preclinical safety assessment of mAbs are non-human primates (NHPs), and this raises important scientific, ethical and economic issues. To investigate evidence-based opportunities to minimize the use of NHPs, an expert working group with representatives from leading pharmaceutical and biotechnology companies, contract research organizations and institutes from Europe and the USA, has shared and analyzed data on mAbs for a range of therapeutic areas. This information has been applied to hypothetical examples to recommend scientifically appropriate development pathways and study designs for a variety of potential mAbs. The addendum of ICHS6 provides a timely opportunity for the scientific and regulatory community to embrace strategies which minimize primate use and increase efficiency of mAb development.
Indexed as
Identifiers
What 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.