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The Long and Winding Road
Published in Norman Begg, The Remarkable Story of Vaccines, 2023
The aim of these preclinical studies is to look for side effects and determine whether the vaccine can produce immune responses. The first animal studies are usually done in rats or mice. Later studies usually use larger animals, including monkeys. Several different doses will be tested to work out which is best to go forward into human studies. The safety of the vaccine is checked by looking for evidence of inflammation, effects on the immune system and the vital organs. Other studies look for the appearance of antibodies after vaccination, to provide clues on whether the vaccine will be effective. If these are promising, a so-called challenge study is often carried out. The animal is vaccinated, then exposed to the infectious disease to see if they are protected. This may sound unethical; however, a challenge study only involves a handful of animals, and because the information they generate is so useful, it avoids using larger numbers of animals in other less informative studies.
Glomerular Barrier Behaves as an Atomically Precise Bandpass Filter in a Sub-nanometre Regime *
Published in Valerio Voliani, Nanomaterials and Neoplasms, 2021
Du Bujie, Xingya Jiang, Anindita Das, Qinhan Zhou, Yu Mengxiao, Rongchao Jin, Jie Zheng
Hydrogen tetrachloroaurate (Fisher Scientific) was used for the synthesis of AuNCs. All other chemicals were obtained from Sigma-Aldrich and used as received, unless specified. Gold in the urine, blood and organs was detected by an Agilent 7900 ICP-MS. The luminescence spectra of Au25SGw, Au25SG18 and Au22SG18, Au22SG18 were collected with a PTI Quanta Master 30 Fluorescence Spectrophotometer. Blood-vessel images and optical images of kidneys and tumours were taken with an IX-71 microscope (Olympus). EM images of the kidney were recorded with a 120 kV Tecnai G2 spirit transmission electron microscope (FEI) equipped with a LaB6 source. Animal studies were performed according to the guidelines of the University of Texas System Institutional Animal Care and Use Committee. Female BALB/c mice (BALB/cAnNCr, strain code 047, 6–8 weeks old, weighing 20–25 g) were purchased from Envigo. Female nude mice (Athymic NCr-nu/nu, strain code 069, 6–8 weeks old, weighing 20–25 g), were also purchased from Envigo for the tumour-targeting study. All mice were randomly allocated and four mice were housed per ventilated cage under standard environmental conditions (23 ± 1°C, 50 ± 5% humidity and a 12/12 h light/dark cycle) with free access to water and standard laboratory food.
The Regulatory Process and Gene Therapy
Published in Kenneth L. Brigham, Gene Therapy for Diseases of the Lung, 2020
Animal studies are usually needed and informative in testing of new products prior to human use, even though they provide imperfect predictions about effects in humans (though see Sect. IV, below). An animal species should be chosen that can be infected by the vector class in use, and if possible an animal that provides a model of the biological activity of the product. It will sometimes be possible to achieve an animal model of the disease. The appropriate species will vary, and uniform use of particular animal species such as primates is not mandated by CBER. The route of administration intended for clinical trials should be used if possible, as well as intravenous administration in certain cases. The dose range tested should include at least one dose within and one dose above the proposed clinical range, and should attempt to determine a toxic dose.
Proteomics-wise, how similar are mouse and human platelets?
Published in Platelets, 2023
Patricia Martínez-Botía, Patricia Villar, Graciela Carbajo-Argüelles, Zacaria Jaiteh, Andrea Acebes-Huerta, Laura Gutiérrez
Although there are obvious differences between mice and humans, the use of mice as preclinical models is sufficiently justified by the conservation of physiological, anatomic, and genetic features.1 Needless to say, preclinical models have provided essential knowledge and facilitated various clinical applications that range from surgery, and vaccine development, to diagnosis and treatment of disease, amongst others. However, there are social, scientific, and ethical concerns regarding their usage.2 The detailed knowledge acquired so far from interspecies studies, makes it clear that conclusions drawn from animal studies cannot be carelessly transferred to humans. Still, some studies require a living organism, which allows observation and experimental manipulation, in order to answer biological questions where multiple tissues or systems contribute to health and disease. In parallel, in vitro tools with increasing levels of complexity (i.e., human organoids) are being developed, which can potentially substitute many in vivo studies.3 All in all, many variables have to be pondered before engaging in animal studies, and always bearing in mind that, ultimately, the experimental option has to translate into a benefit for human clinical research.
Clinical and immunologic implication of neo-osteogenesis in chronic rhinosinusitis
Published in Expert Review of Clinical Immunology, 2023
So Yeon Yoon, Seung-No Hong, Yan Lee, Dae Woo Kim
Historically, animal models for CRS osteitis have primarily utilized rabbits due to the ease of surgical access to the maxillary sinuses, the possibility of sinus occlusion, and the reproducibility of inducting infections. Inducing sinusitis through experimental means in animal models has revealed the following histological alterations in bone tissue :1) osteoclastic resorption [18,19,60–64], 2) osteoblastic neo-osteogenesis [18,19,60,62–64], 3) fibrosis [19,60–62], 4) periosteal thickening [19,59,63,64], and 5) Haversian canal changes [61,62]. However, these animal studies have some limitations. Because CRS is a multifactorial disease that encompasses inflammatory, environmental, host, and genetic aspects, bacterial pathogens represent only a single etiological component. Therefore, the use of animal models that focus on a single factor, such as infection, may not accurately reflect the complexity of human disease. In addition, the rabbit osteitis model has disadvantages, such as short follow-up periods, higher housing costs, and unavailability of genetic manipulation.
Targeting adverse effects of antiseizure medication on offspring: current evidence and new strategies for safety
Published in Expert Review of Neurotherapeutics, 2023
Leihao Sha, Xihao Yong, Zhenhua Shao, Yifei Duan, Qiulei Hong, Jifa Zhang, Yunwu Zhang, Lei Chen
However, several limitations may delay drug development. First, there is insufficient evidence to confirm the safety of existing drugs during pregnancy and lactation. Only a few clinical studies have reported the biological barrier transport of anti-seizure medications; these studies had small sample sizes and high heterogeneity. To further improve the current treatment status for women with epilepsy during pregnancy/lactation, more adequate, larger samples, and multiregional clinical studies are needed to determine the safety and efficacy of existing anti-seizure medications. In addition, additional transporters of antiseizure medications need to be discovered, which is vital for understanding transport mechanisms. Such an effort will require not only animal studies but also human tissue experiments. This will facilitate the implementation of experiments in clinical practice. Future studies in this field could focus on the abovementioned limitations, and novel and safer anti-seizure medications could be developed in the next decade.