Guideline limit volumes for dosing animals in the preclinical stage of safety evaluation

Rm, Hull

doi:10.1177/096032719501400312

Cited by 35 publications

(12 citation statements)

References 2 publications

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“…In this www.nature.com/scientificreports/ study due to the route of administration and the maximum volume in ml/kg that can be given by o.s. in mice 28 , we consider three dose of SSF as high dose of 15 ml/kg, medium of 7.5 ml/kg and low 3 ml/kg, to gradually obtain a greater surface of gastric mucosa in contact with SSF 21 . Considering the proteins content in the SSF the respective dosage as mg/kg were respectively 384 mg/kg, 192 mg/kg and 76,8 mg/kg.…”

Section: Discussionmentioning

confidence: 99%

Protective effect of snail secretion filtrate against ethanol-induced gastric ulcer in mice

Gugliandolo

Cordaro

Fusco

et al. 2021

Sci Rep

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Gastric ulcer or peptic ulcer is a common disease worldwide. Basically, it develops when there is an imbalance between the protective and aggressive factors, especially at the luminal surface of epithelial cells. Thus, there is a constant interest in research new drugs for treatment of gastric ulcer. The snail secretion is a dense mucous, that covers the external surface of the snails, with important functions for the survival of snails. The biological proprieties of snail Helix Aspersa Muller mucus it has been known for centuries to treat human disorders in particular for skin disease. Recently the use of snail mucus has seen a worldwide increase, as a component in cosmetic product and it has been used in particular for the management of wound and skin disorders. In this study we use a murine model of ethanol intragastric administration which has been widely used to test the drugs efficacies and to explore the underlying mechanism for gastric ulcer development. The intragastric ethanol administration causes several mucosal damages and an induction of a severe inflammatory response. Our results show a significant protective effect of snail secretion filtrate in reducing macroscopic and histological lesions, as well the protective effect on mucus content, oxidative stress and inflammatory response. In conclusion this study demonstrate the protective effect of intragastrical snail secretion filtrate, in a model of ethanol-induced gastric ulcer in mice, suggesting its possible useful use in the treatment or prevention of gastric ulcer.

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Section: Discussionmentioning

confidence: 99%

Protective effect of snail secretion filtrate against ethanol-induced gastric ulcer in mice

Gugliandolo

Cordaro

Fusco

et al. 2021

Sci Rep

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“…The pharmaceutical industry, in particular, has investigated the levels of dosing compatible with animal welfare and valid science. 2 In the preclinical stage of the safety evaluation of new drugs it is normal practice to use multiples of the 'effective dose' in order to attempt to establish the necessary safety margins. Where chemicals are of low toxicity or are only poorly soluble in acceptable formulations, a large volume may be required to be given to individual animals to satisfy both scientific and regulatory requirements.…”

Section: Introductionmentioning

confidence: 99%

A good practice guide to the administration of substances and removal of blood, including routes and volumes

Diehl

Hull

Morton

et al. 2001

J of Applied Toxicology

1,279

707

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This article is the result of an initiative between the European Federation of Pharmaceutical Industries Associations (EFPIA) and the European Centre for the Validation of Alternative Methods (ECVAM).Its objectives are to provide the researcher in the safety evaluation laboratory with an up-to-date, easyto-use set of data sheets to aid in the study design process whilst at the same time affording maximum welfare considerations to the experimental animals.Although this article is targeted at researchers in the European Pharmaceutical Industry, it is considered that the principles underpinning the data sets and refinement proposals are equally applicable to all those who use these techniques on animals in their research, whether in research institutes, universities or other sectors of industry. The implications of this article may lead to discussion with regulators, such as those responsible for pharmacopoeial testing.There are numerous publications dealing with the administration of test substances and the removal of blood samples, and many laboratories also have their own 'in-house' guidelines that have been developed by custom and practice over many years. Within European Union Directive 86/609EEC 1 we have an obligation to refine experiments to cause the minimum amount of stress. We hope that this article will provide background data useful to those responsible for protocol design and review.This guide is based on peer-reviewed publications whenever possible, but where this is not possible we have used 'in-house' data and the experience of those on the working party (as well as helpful comments submitted by the industry) for a final opinion. The guide also addresses the continuing need to refine the techniques associated with the administration of substances and the withdrawal of blood, and suggests ways of doing so. Data-sharing between laboratories should be encouraged to avoid duplication of animal work, as well as sharing practical skills concerning animal welfare and scientific problems caused by 'overdosing' in some way or another. The recommendations in this guide refer to the 'normal' animal, and special consideration is needed, for instance, during pregnancy and lactation. Interpretation of studies may be confounded when large volumes are administered or excessive sampling employed, particularly if anaesthetics are used. Copyright The objectives of the Technical Sub group of EFPIA/ ECVAM were as follows:(i) to provide a guide on administration volumes for use in common laboratory species used in toxicity studies required by regulatory authorities; (ii) to provide consensus dosage levels for routine use that represent good practice in terms of animal welfare and practicality; (iii) to produce a guide to dosage levels representing the upper limit of common practice, which leaves scope to make the case for special investigations. Some of these suggested maximum values have been obtained from recent literature, 3,4 but appear high when compared with 'good practice' values. The need for careful attention...

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“…In order to eliminate possible toxic effects resulted from fluid overload, the volume of 10 mL/kg administered intravenously was not exceeded. 19,20 In this study, 420 mg/kg of D-ribose was used to meet the group received 4.2% D-ribose solution at 420 mg/kg (10 mL/kg), intravenously, once daily for 28 days; saline group received 0.9% saline solution, intravenously, once daily for 28 days and served as control; satellite group received 4.2% D-ribose solution at 420 mg/kg (10 mL/kg), intravenously, once daily for 28 days but were euthanized on day 15 after the last D-ribose injection to allow for extended observation period for any late-occurring effects.…”

Section: Discussionmentioning

confidence: 99%

“…recommendations for intravenous injection of isotonic solutions (around 300 mOsm/L) in laboratory animals. 19,20 Injection of hypertonic solutions including D-ribose may induce undesirable effects such as hemolysis and perivascular irritation especially when repeated dosing is used. 19,20 Previous clinical and preclinical toxicity studies have focused mainly on oral administration of Dribose.…”

Section: Discussionmentioning

confidence: 99%

“…To reduce damage to the sensitive ear veins due to repeated daily injections, the smallest needle possible was used, and the right and left ear veins were used alternatively. 19 Rabbits were restrained in a wooden rabbit restrainer (locally produced, Jordan) for injection. Lamp heat was used to help dilate the vein before injection.…”

Section: Animals and Study Designmentioning

confidence: 99%

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Evaluation of α-d-ribofuranose (d-ribose) toxicity after intravenous administration to rabbits

et al. 2012

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Rapid intravenous administration of D-ribose may result in a significant reduction in cellular damage in patients with sudden ischemic insults. The development of an effective and clinically safe therapeutic regimen using the intravenous route in critically ill patients especially with cardiac diseases requires a comprehensive assessment of potential toxic effects of the drug in laboratory animals and in human beings. The potential clinical, behavioral, hematological, biochemical, gross pathological and histological toxic effects associated with the intravenous administration of D-ribose in rabbits for 28 days were evaluated in this study. Except for an increase in neutrophil percentage in male rabbits in the D-ribose-treated groups, there were no statistically significant toxic effects induced by daily intravenous administration of the drug in male and female rabbits. Results of this study suggest that D-ribose administered intravenously for 28 days in the rabbit exhibited no toxicity at 420 mg/kg.

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Guideline limit volumes for dosing animals in the preclinical stage of safety evaluation

Cited by 35 publications

References 2 publications

Protective effect of snail secretion filtrate against ethanol-induced gastric ulcer in mice

Protective effect of snail secretion filtrate against ethanol-induced gastric ulcer in mice

A good practice guide to the administration of substances and removal of blood, including routes and volumes

Evaluation of α-d-ribofuranose (d-ribose) toxicity after intravenous administration to rabbits

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