【正文】 高劑量應顯示出一定的毒性。：A general guide for the evaluation of new chemical entities would be that toxicology studies of a minimum duration of 14 days are required to support singledoes exposure of a new drug candidate in normal volunteers in phase 1.翻譯：評價新化學實體的通用指南應該是一個為期14天以上毒理學研究需要支持正常的志愿者在第I階段的單劑量接觸一個新的候選藥物。76. Toxicology studies of 30 days duration are required to support clinical studies of 7 to 10 days duration.翻譯：710天的臨床研究則需要30天的毒理學研究來支持 studies of greater than 7 to 10 days up to 30 days duration require the support of at least 90 days toxicology studies.而超過7至10天直至30天的臨床研究則需要有至少90天的毒理學研究來支持。Clinical studies 臨床研究； toxicology studies 毒理學研究78.:These requirements illustrate the need to plan ahead in drug development中文翻譯: 這些要求應在計劃藥物開發(fā)之前就明確說明。7 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.未來臨床試驗的持續(xù)時間和大概的時序安排需要提前好好地深思熟慮，以便做好安排并進行適當?shù)亩纠韺W研究，以支持臨床計劃并避免任何延誤。：Two types of safety test are used to detect the ability of the drug candidate to produce tumours in man.翻譯：兩種類型的安全測試是用來檢測候選藥物在人體引起腫瘤的能力。：The first are short—term in vitro genotoxicity tests, for example bacterial tests.譯文：第一類是短期的體外遺傳毒性試驗，例如細菌試驗。secondarelongtermanimalcarcinogenicitystudieswhichareconductedinmiceandrats。theirlengthofoften2yearscoversalargepartofthelifespanoftheanimal第二類是在小鼠和大鼠身上進行的動物長期致癌性研究；他們往往在兩年的時間長度覆蓋了動物壽命的很大一部分。:Mice and rats are used because of their relative 知識，大大有助于解釋研究結果。 toxicology and carcinogenicity studies are conducted in order to obtain approval to test and finally to market a product for chronic administration to man. 翻譯：開展長期毒理學和致癌性研究是為了獲得試驗的批準，并最終向市場推出了人類長期服藥的產(chǎn)品。 8原文:These studies may need to start during the late preclinical phase in order to“support” the subsequent clinical program！這些研究可能需要在臨床前后期/早期臨床階段就開始，以“支持”隨后的臨床計劃。 toxicity studies will normally include toxicity studies of six and twelve months duration in two species (one nonrodent)長期毒性試驗通常包括兩個物種（一個為非嚙齒類）的612個月持續(xù)時間的毒性研究。：Any toxicity previously detected may be investigatd more close ,for example extra enzymes looked blood samples.翻譯：以前測試到的任何毒性會進行更密切地調查，例如在血液樣本中觀測到額外的酶。 89. Reproductive toxicology is that part of toxicology dealing with the effect of pounds on reproduction fertility , foetal abnormalities, postnatal development. 生殖毒理學則是指涉及化合物對繁殖能力、胎兒畸形，產(chǎn)后發(fā)育的影響的部分毒理學。90. Prior to clinical studies in women of childbearing age, regulatory authorities require teratology data from two species (normally rat and rabbit ) as well as clinical data from male volunteers.在育齡婦女的臨床研究之前，監(jiān)管部門要求有兩個物種（通常是大鼠和家兔）以及男性志愿者的臨床資料畸形學的數(shù)據(jù)。 reproductive data are required prior to clinical studies in male subjects.在男性受試者的臨床研究之前，則不要求生殖方面的數(shù)據(jù)。 effects of pounds on reproduction differ with the period of the reproductive cycle in which exposure takes place and studies aredesigned to look at these phases.化合物對生殖的影響隨著暴露發(fā)生的生殖周期而不同，要設計研究來觀測這些階段。9 Teratology`39。39。 studies are designed to detect foetal abnormalities，fertility studies to investigate the pounds39。 effect on reproductive performance，And peri and postnatal studies to study the development of pups.設計畸形學研究來檢測胎兒畸形，生殖研究來調查化合物對繁殖性能的影響，產(chǎn)前和產(chǎn)后研究來研究幼崽的發(fā)育。