制药工程专业英语(药物研发PPT).pptx

Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;toxicology noun 毒理学、毒物学/toxicologist 毒理学家 toxicological adj 有毒性的 administration noun 药品监督管理局（Food and Drug Administration，FDA） reversible/irreversible 可逆的/不可逆的 reversible reaction/irreversible reaction 可逆反应/不可逆反应 if possible 如果可能的话;The toxicological studies required for the evaluation of a drug candidate in man will be relevant to its proposed clinical use in terms of route of administration and duration of treatment of the clinical studies. ; Countries，including UK，USA，Australia，and Nordic countries，have regulatory guidelines which relate the duration of treatment allowed in man to the length of toxicity studies required in two species. Points from the guidelines are referenced in the subsequent sections. ;Part sixth Safety evaluation （安全评估）;The main aim of the subsequent sub-acute toxicity tests is to determine whether or not the drug candidate is adequately tolerated after administration to animals for a prolonged period as a guide to possible adverse reactions in man.;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;The duration and approximate timings for future clinical trials need to be considered well in advance in order to schedule and conduct the appropriate toxicology studies to support the clinical program and avoid any delays.;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;Part sixth Safety evaluation （安全评估）;The effects of 59 compounds on reproduction differ with the period of the reproductive cycle in which exposure takes place and studies are designed to look at these phases. Teratology studies are designed to detect fetal abnormalities，fertility studies to investigate the compounds effect on reproductive performance，and peril- and post-natal studies