A5088593926- Animal testing and alternatives
- Effects and risks of endocrine disrupting chemicals
- Pesticide Exposure and Toxicity
- Immunotoxicology and immune responses
- Environmental Toxicology and Ecotoxicology
- Carcinogens and Genotoxicity Assessment
- Biosimilars and Bioanalytical Methods
- Computational Drug Discovery Methods
- Agricultural safety and regulations
- Veterinary Pharmacology and Anesthesia
- Congenital Diaphragmatic Hernia Studies
- Statistical Methods in Clinical Trials
- Congenital Anomalies and Fetal Surgery
- Insect and Pesticide Research
- Monoclonal and Polyclonal Antibodies Research
- Science, Research, and Medicine
- Pelvic floor disorders treatments
- Liver Disease Diagnosis and Treatment
- Congenital gastrointestinal and neural anomalies
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical and Antibiotic Environmental Impacts
- Viral Infectious Diseases and Gene Expression in Insects
- Trauma Management and Diagnosis
- Chemical Safety and Risk Management
- Liver Disease and Transplantation
National Centre for the Replacement Refinement and Reduction of Animals in Research
2015-2024
AstraZeneca (United Kingdom)
2016
Youth & Family Services
2014
University of Auckland
1987
Abstract New approach methodologies (NAMs) can deliver improved chemical safety assessment through the provision of more protective and/or relevant models that have a reduced reliance on animals. Despite widely acknowledged benefits offered by NAMs, there continue to be barriers prevent or limit their application for decision-making in assessment. These include related real and perceived scientific, technical, legislative economic issues, as well cultural societal obstacles may relate...
Abstract Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs other chemicals, may ultimately play important role in regulatory decision making. Not only can the development application of AOPs pave way improved evidence‐based approaches hazard risk assessment, there is also promise a significant impact on animal welfare, with reduced reliance animal‐based methods. The establishment useable coherent knowledge framework...
Toxicity studies using mammalian species are generally required to provide safety data support clinical development and licencing registration for potential new pharmaceuticals. International regulatory guidelines outline recommendations the order (rodent and/or non-rodent) number of species, retaining flexibility a diverse range drug modalities in manner relevant each specific medicine. Selection appropriate toxicology involves consideration scientific, ethical practical factors, with...
In 2022, the European Chemicals Agency issued advice on selection of high dose levels for developmental and reproductive toxicity (DART) studies indicating that highest tested should aim to induce clear evidence without excessive severe suffering in parental animals. addition, a recent publication advocated 10% decrease body weight gain be replaced with bodyweight as criterion adequacy. Experts from Centre Ecotoxicology Toxicology evaluated these developments their potential impact study...
Short term toxicity studies are conducted in animals to provide information on major adverse effects typically at the maximum tolerated dose (MTD). Such important from a scientific and ethical perspective as they used make decisions progression of potential candidate drugs, set levels for subsequent regulatory studies. The MTD is usually determined by parameters such clinical signs, reductions body weight food consumption. However, these assessments often subjective there no published...
Adoption of a blood microsampling technique can reduce or avoid the use satellite animals (rodents) for toxicokinetics other purposes in discovery and toxicology studies provides refinements applicable both rodents larger animals. Microsampling increase scientific value data obtained from rodent during drug (agro)chemical development, enabling multiple endpoints to be investigated compared an individual animal same way as non-rodents. A cross-sector survey was developed understand current...
Scientists face growing pressure to move away from using traditional animal toxicity tests determine whether manufactured chemicals are safe. Numerous ethical, scientific, business, and legislative incentives will help drive this shift. However, a number of hurdles must be overcome in the coming years before non-animal methods adopted into widespread practice, particularly regulatory, global perspectives. Several initiatives nevertheless underway that promise increase confidence newer...
The acute toxicity 'six-pack' is a suite of tests for hazard identification and risk assessment, primarily conducted the classification labelling industrial chemicals agrochemicals. designed to provide information on health hazards likely arise from short-term exposure via inhalation, oral dermal routes, including potential eye skin irritation/corrosion sensitization. component currently rely heavily use experimental animals. In 2017, UK National Centre Replacement, Refinement Reduction...
In silico approaches are becoming increasingly important tools in toxicology. This is especially the case for cosmetics industry, where growing numbers of regions implementing bans on vivo testing ingredients and products, resulting an increased need to be able generate safety data vitro and/or silico. 'In silico' include results obtained from (quantitative) structure activity relationship ((Q)SAR) models, chemical categories, grouping, read-across physiologically-based (pharmaco)kinetic...
An international expert working group representing 37 organisations (pharmaceutical/biotechnology companies, contract research organisations, academic institutions and regulatory bodies) collaborated in a data sharing exercise to evaluate the utility of two species within general toxicology studies. Anonymised on 172 drug candidates (92 small molecules, 46 monoclonal antibodies, 15 recombinant proteins, 13 synthetic peptides 6 antibody-drug conjugates) were submitted by 18 organisations. The...
Regulatory decisions surrounding chemical safety are based on human and environmental (ecological) protection goals. Historically, such have relied data from animal toxicity testing to inform hazard risk assessment determine whether chemicals pose a threat or health. Traditionally, mammalian test driven health considerations, studies select species representing different taxa ecological considerations. Crosstalk collaboration between knowledge-streams been limited. This represents barrier...
To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has shown a relatively benign and well-understood safety profile this class, most findings anticipated based on pharmacology. We evaluated whether study is necessary to assess the long-term mAbs. Data First-in-Human (FIH)-enabling were shared 142 mAbs submitted by 11 companies. Opportunities further optimize designs reduce...
An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations, academic institutions and regulatory bodies) has shared data on the use of recovery animals in assessment pharmaceutical safety for early development. These have been used as an evidence-base to make recommendations inclusion toxicology studies achieve scientific objectives, while reducing animal use. Recovery are development provide information potential a toxic effect...
The fish acute toxicity test (TG203; OECD, 2019) is frequently used and highly embedded in hazard risk assessment globally. estimates the concentration of a chemical that kills 50% (LC50) over 96 h exposure considered one most severe scientific procedures undertaken. Over years, discussions at Organisation for Economic Co-operation Development (OECD) have resulted changes to which reduce number used, as well development (potential) replacement (TG236, 2013). However, refinement mortality...
The market for biotherapeutic monoclonal antibodies (mAbs) is large and growing rapidly. However, attrition poses a significant challenge the development of mAbs, biopharmaceuticals in general, with associated costs resource animal use. Termination candidate mAbs may occur due to poor translation from preclinical models human safety. It critical that industry addresses this problem maintain productivity. Though pharmaceuticals there are specific challenges related antibody-based products....