Unit 8. Text A．Development of New Drug （Ⅰ） 新药的发展（Ⅰ） 第3部分 Unit 8. Text A．Development of New Drug （Ⅰ） 新药的发展（Ⅰ） 主讲教师：黄昆

目的是为了 习惯用法： aim at + n. Drug development aims to produce a novel therapeutic agent which is superior in efficacy to existing remedies and which causes less frequent or less severe adverse effects. 不利影响 优越于 side effect 副作用 注：to为prep 华中科技大学远程教学

e.g. It is very likely that there were no life on mars. 随着…的发展 单克隆抗体 With the development of genetic engineering and the production of monoclonal antibodies it is likely that even more agents will be produced artificially. 句型：很有可能… adv.人工地 e.g. It is very likely that there were no life on mars. 华中科技大学远程教学

adj.法定的 Although they serve to protect the public and are seen to do so, the statutory procedures that must be followed in applying for a license for a new drug add greatly to the costs and time of development. 从句修饰procedures 华中科技大学远程教学

Drug development strategies ——药物研发战略 1．Serendipity （n.意外发现）, luck and intuition （eg. Penicillin 青霉素） 2．Molecular roulette（分子随机组合） 3．Minor structural changes in existing agents 4．Programmed basic research with synthesis of specific chemical （特定化学物质合成的程序化研究 ） （eg.histamine H2 antagonists 组胺拮抗剂 ） 5．Clinical observation of drug action in practice （药效的临床观察 ） 最有效 传统 华中科技大学远程教学

Experimental pharmacology ——实验药理 Aim： Whether does the drug have the desired profile of action in model systems. Models: bacteria, isolated tissues, perfused （被灌注的） organs and so on; 药物作用 华中科技大学远程教学

Toxicological assessment ——毒理评价 Acute toxicity （急性毒性） is less important as long as LD50 （the dose that kills 50% of animals） is not close to the ED50 （the dose causing 50%of maximum pharmacological response） Therapeutic index （TI）= 半数致死量 半数有效量 治疗指数 华中科技大学远程教学

2．Duration（持续时间） of treatment Chronic toxicity（慢性毒性） testing is more relevant to clinical application and should take place along the following lines: 1．Route of administration（给药途径）, dose range, dose frequency, plasma levels≥two species 2．Duration（持续时间） of treatment 3．Haematological（血液学的） and biochemical measurements 华中科技大学远程教学

Attention Effects on fertility（生育力） Teratogenic effects（致畸作用） on development of the embryo Mutagenicity（致突变性） or an increased rate of mutation Carcinogenicity（致癌性） or induction of tumours（肿瘤） 华中科技大学远程教学

Examples Paradoxically, thalidomide（萨利多胺）, which was the cause of the tragedy that led to stricter drug regulation and toxicology tests, is not teratogenic（致畸态） in mice or rats but has a teratogenic effect in humans, causing gross limb deformities（肢体畸形 ）. 华中科技大学远程教学

Exercise There be 句型： 1．翻译：There is considerable controversy … have been reported. 由于种属间特别是人与属火狗之间的诸多差异早有报道，所以，对于常规毒理测试的价值，人们在看法上有很大分歧。 2．转换：There is disagreement over the relevance of … to man. Some researchers think that the result of carcinogenicity studies in animals should differ from that in man. 华中科技大学远程教学

Unit 8. Text B．Development of New Drug （Ⅱ） 新药的发展（Ⅱ） 华中科技大学远程教学

Clinical evaluation ——临床评价 Drugs for use in rare diseases, or in life-threatening and yet untreatable states, may be evaluated in patient groups at an earlier stage than those with readily measurable effects on common diseases. 形容词复合词 n+v-ing/ed：poverty-stricken（贫困的） money-making （赚钱的） 危及生命的 在早期 华中科技大学远程教学

Phase 1 Small scale in normal volunteers 　　Assessment of clinical, hematological and biochemical evidence 　　Be performed by experienced（有经验的） staff, under medical supervision, in premises with appropriate resuscitative facilities and support. 在…前提下 adj.复苏的 华中科技大学远程教学

Phase 2 Patients with the appropriate disease Controlled studies（控制组） under single or double-blind conditions Comparisons in active placebo or known active agents. 双盲测试 （实验者和受实验者对实验细节均无所知） 安慰剂，空白对照剂 华中科技大学远程教学

Phase 3 Large scale clinical trials After the phase, evidence is assembled, then drug may be submitted to the regulatory authorities for a product licence. 监管当局 v.向…呈交〔递送〕 华中科技大学远程教学

Phase 4 Be marketed after hundreds ~ thousands Patients exposed to it for weeks or months Post-marketing surveillance without uniform scheme 接触;接受;面临着 上市后的监督 华中科技大学远程教学

Marketing and promotion ——投入市场和推销 承受，承担 Drug development is borne by the pharmaceutical industry, which justifiable expects to recoup the cost of development when the product is finally marketed. v.补偿, 偿还 投入市场 华中科技大学远程教学

医生 积极地尝试 Physicians should make an active attempt to determine in what way a new drug represents an improvement over existing therapy, and what is the price in terms of adverse effects and actual cost of the drug. 从……角度上； 在……方面 华中科技大学远程教学

as引导时间状语从句 As new drugs may be marketed after studies in only a few hundred or thousand patients, special vigilance（警惕,失眠症） is required in the first few years of use to determine low-frequency, but potential serious adverse effects. prep.还有 华中科技大学远程教学

2．The students took notes as they listened.（listen为延续性动词）学生们边听课边做笔记。 e.g. 1．As years go by，China is getting stronger and richer．随着时间一年一年过去，中国变得越来越富强了。 2．The students took notes as they listened.（listen为延续性动词）学生们边听课边做笔记。 华中科技大学远程教学

Comments 客观证据 New drug development should be examined critically; objective evidence from several sources should be sought to highlight improved （改进的）therapeutic efficacy and reduced（减少的） toxicity in controlled comparison with established （确定的）remedies. 过去分词作形容词 eg. We were deeply moved. You'd better drink boiled water. 华中科技大学远程教学

Exercises 用于新药品促销方面的巨额投资不仅导致了不加区别地使用新药，同时也提高了药品的成本。 Huge investment in the promotion of new drug not only leads to the indiscriminate use of new drug, but also increase the cost of drug. 华中科技大学远程教学

英语翻译练习材料 1．药物研制方法和策略包括偶然发现、分子随机组合、有计划地研究某一特定化学成分的合成等方法。 2．大多数药物都有一个安全剂量上限，超过这一限度，便可能导致产生毒副作用。 3．新药的临床评价必须在动物研究证明有效后方可进行，新药的人体评价可分为四个阶段。 4．发表于著名杂志的有关新药的信息往往比以促销为生的医药代表的介绍更为可信。 华中科技大学远程教学

英语口语练习材料 1．Every man has his faults. 人无完人。 2．Fire and water have no mercy.  水火无情。 3．He who makes no mistakes makes nothing.   　　想不犯错误，就一事无成。 4．It is hard to please all. 众口难调。  5．Like author, like book.  文如其人。 6．No one can call back yesterday.  昨日不会重现。 7．Pleasure comes through toil.  苦尽甘来。 华中科技大学远程教学