给药体积血样采集量课题.ppt

A Good Practice Guide to the Administrationof Substances and Removal of Blood,Including Routes and Volumes JOURNAL OF APPLIED TOXICOLOGY J. Appl. Toxicol. 21, 15–23 (2001) Key words: blood volumes; blood removal; administration substances; laboratory animals; refinement. objectives 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, easy to-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. objectives (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 animalwelfare 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. Oral route . On occasions, it may be necessary to restrict the animals’ food intake before dosing. This factor may affect absorption. Large dose volumes (40 ml kg-1) have been shown to overload the stomach capacity and pass immediately into the small bowel.5 Larger volumes may also reflux into the oesophagus. The duration of fasting will depend upon the feeding pattern of the species, the starting time for food restriction, the physiology of the species, the length of time of dosing, diet and the light cycle.6 It is recommended that for accuracy of dosing and to avoid dosing accidents liquids are administered by gavage. Parenteral routes.肠道外给药 For substances administered parenterally the dose volume used stability of the formulation before after administration, pH, viscosity,osmolality, bu