【正文】 effect on reproductive performance，And peri and postnatal studies to study the development of pups.設(shè)計(jì)畸形學(xué)研究來檢測(cè)胎兒畸形，生殖研究來調(diào)查化合物對(duì)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。39。 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(duì)生殖的影響隨著暴露發(fā)生的生殖周期而不同，要設(shè)計(jì)研究來觀測(cè)這些階段。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(gè)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(xué)的數(shù)據(jù)。：Any toxicity previously detected may be investigatd more close ,for example extra enzymes looked blood samples.翻譯：以前測(cè)試到的任何毒性會(huì)進(jìn)行更密切地調(diào)查，例如在血液樣本中觀測(cè)到額外的酶。 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(xué)和致癌性研究是為了獲得試驗(yàn)的批準(zhǔn)，并最終向市場(chǎng)推出了人類長期服藥的產(chǎn)品。animal第二類是在小鼠和大鼠身上進(jìn)行的動(dòng)物長期致癌性研究；他們往往在兩年的時(shí)間長度覆蓋了動(dòng)物壽命的很大一部分。ofthepartayearsoftenlengthandinarestudiesanimalare：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(cè)試是用來檢測(cè)候選藥物在人體引起腫瘤的能力。Clinical studies 臨床研究； toxicology studies 毒理學(xué)研究78.:These requirements illustrate the need to plan ahead in drug development中文翻譯: 這些要求應(yīng)在計(jì)劃藥物開發(fā)之前就明確說明。：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(píng)價(jià)新化學(xué)實(shí)體的通用指南應(yīng)該是一個(gè)為期14天以上毒理學(xué)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(gè)新的候選藥物。73..Two to four week (daily dosing) studies are requird, using the same route of administration as in man, in two species (one nonrodent) prior to administration of the pound to man. 使用與人相同的給藥途徑，在先于人的該化合物的給藥前，兩個(gè)物種（一個(gè)為非嚙齒類）的兩到四個(gè)星期（每日劑量）的研究是必需的。71..Results provide a guide to the maximum tolerated doses in subsequent chronic toxicity tests, aid selection of does levels, and identify target organs.翻譯：（所得的）結(jié)果給隨后的慢性毒性試驗(yàn)，提供了一個(gè)最大耐受劑量的參考值，有助于劑量水平的選擇，以及確定靶標(biāo)器官。69. Points from the guidelines are referenced in the subsequent sections.指南的要點(diǎn)引用在隨后的章節(jié)里。：The size and frequency of the doses and the duration of the toxicology studies are major determinants of permissible tests in man.翻譯：劑量的大小和使用頻率，以及毒理學(xué)研究的持續(xù)時(shí)間是人體獲準(zhǔn)測(cè)試的主要決定因素。6 It is also important to interrelate drug response to blood levels in humans and blood levels in various animals pecies. 使藥物在人類的血中濃度和各種動(dòng)物物種的血中濃度的響應(yīng)建立相互關(guān)聯(lián)也是重要的。attention.這就意味著，在早期人類研究中這些器官和組織可以特別注意而得到監(jiān)測(cè)。withbetissuesorgansstudiesearlythat60. It may also be appropriate to identify a substance for possible use in the management of overdosage , particularly if the therapeutic margin of the drug candidate is small.翻譯：特別是如果該候選藥物的治療范圍很小時(shí)，確定一種物質(zhì)在過劑量的管理規(guī)范下的可能用法，這也可能是適當(dāng)?shù)摹?8．Any synergism or antagonism of drug effects should be investigated, and any necessary warning issued to clinical investigators.應(yīng)當(dāng)對(duì)藥物的任何協(xié)同作用或拮抗作用進(jìn)行研究，任何必要的警告都應(yīng)該告訴臨床研究者。the effects on gross behavior can also be studied所研究的身體系統(tǒng)包括心血管系統(tǒng)，呼吸系統(tǒng)和神經(jīng)系統(tǒng)；對(duì)總體行為的影響也會(huì)研究。species. 在候選藥物給人服用之前，它關(guān)于主要系統(tǒng)的藥理作用往往在大量的物種上進(jìn)行了研究。numberinoften systemsonpharmacologicaltoisdrugorclinicalofthedrugofcoversufficientitproblembewill in development the shelflife may be limited to seve