英语翻译软件翻译的都不通顺.Species specifi cityAnother term that is frequ

英语翻译
软件翻译的都不通顺.
Species specifi city
Another term that is frequently bandied about in the biotech drug
world is ‘species specifi city’.This means that you can’t take your drug candidate and inject it into a rodent or nonrodent species in your
toxicology studies and assume this is going to be acceptable to the
regulatory agencies.In the 1980s when the interferons were being
developed,companies assumed they could use a small molecule drug
development programme for any new biotech drug.They injected
rodents with recombinant interferons and nothing happened,not
because they were not toxic,but because they have little or no
pharmacological activity in rodents.The receptors either don’t exist or are different enough from the human receptors to cause poor binding
of the drug to its putative receptor.To evaluate the toxicity of biologics,the drug candidate must be shown to have pharmacological activity in
the animal model chosen for preclinical studies.This has necessitated
using primate models for many biopharmaceuticals,because biotech
drug receptors are not necessarily found in lower species.
But what if the drug candidate only binds to the human or
chimpanzee receptor?These types of drugs are more challenging
to develop.Some biotech drugs have been tested in chimpanzees
but the data obtained are limited to pharmacokinetic and clinical
chemistry,because necropsies are no longer permitted.In fact,
experimentation with chimpanzees is now banned in many regions,
notably the EU.One approach for these drug programmes is to develop the
analogous molecule in a lower species.An anti-TNF mouse version of
Remicade (infl iximab) (eg,cV1q) was developed and used for repeat
dose and reproductive toxicology studies in mice.Another example is
Raptiva (efalizumab),for which a surrogate antibody that binds CD11a
in mice was developed (muM17) and used in repeat dose toxicology,reproductive toxicology,and toxicokinetic preclinical studies.The ICH (International Conference on Harmonisation) guidance
(ICH S6) for preclinical development of biopharmaceuticals states
that safety evaluation should normally include two relevant species
(ie,two species in which the drug is pharmacologically active).
However,when only one relevant species can be identifi ed (or when
the biological activity of the biopharmaceutical is well understood)
it is acceptable to do toxicity testing in only one species.5 Note that
the regulatory authorities will require studies demonstrating degree
of binding of the drug to its receptor or epitope in various species to
support the choice of species for toxicity testing.

物种特异性
另一个经常被谈论在生物技术药物
世界是物种特异性的.这意味着你不能把你的候选药物和注射到你的啮齿类动物或nonrodent物种
毒理学研究,认为这将是可以接受的
监管机构.在上世纪80年代,当干扰素被
发达,公司认为他们可以用一种小分子药物
任何新的生物技术药物开发计划.他们注射
重组干扰素并没有发生什么事的啮齿类动物,不
因为他们是没有毒的,但是因为他们很少或根本没有
在啮齿类动物的药理活性.受体要么不存在或是足够不同的从人类受体造成贫穷的结合
其公认的受体的药物.对生物的毒性,药物的候选人必须证明有药理活性
临床前研究的动物模型的选择.因此有必要
使用灵长类动物模型的许多生物制药,因为生物技术
药物受体不一定是在较低的物种.
但是如果候选药物只有结合人或
黑猩猩的受体?这些类型的药物是更具挑战性的
发展.一些生物技术药物已经过测试,在黑猩猩
但得到的数据是有限的药代动力学和临床
化学,因为验尸不再允许.事实上,
实验与黑猩猩是目前在许多地区禁止,
特别是欧盟的.这些药物方案的方法之一是开发
类似的分子在一个较低的物种.抗TNF鼠标版
英夫利昔单抗（INFL iximab）（例如,cv1q）的开发和用于重复
小鼠生殖毒理学研究.另一个例子是
Raptiva（efalizumab）,并结合CD11a替代抗体
在小鼠的开发（mum17）和用于重复剂量毒性,生殖毒性,和毒代动力学的临床研究.ICH（国际协调会议）指导
（ICH S6）的生物药品的临床前开发状态
安全评价一般应包括两个相关的物种
（IE,两种药物的药理活性）.
然而,当只有一个相关的物种可以被确定（或当
的生物制药的生物活性很好理解）
这是要做的只有一种可以接受的毒性试验.5注意
监管当局将需要研究显示度
药物的受体或抗原表位的不同物种的结合
支持对毒性试验树种的选择.
（PS：请配合脑补阅读）
再问： 你这翻译机器翻译的不行，读不通的