新药研发PPT.ppt

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5.An overview of new drug development
Developing a new drug is a highly complex, time-consuming, risky and costly process.
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complex and time-consuming
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③ With the development of genetic engineering（基因工程） more drugs will be produced artificially. e.g. the first genetically engineered drug is rh-insulin (for the treatment of diabetes ) and was first marketed in America in 1982 .
adverse reaction（不良反应）: any bad effect or undesirable effect caused by drug use at normal dose（正常剂量）
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new chemical entity(新化学实体): new compound shows pharmacological activity against certain disease, which is also called lead compound(先导化合物) or drug candidate(候选药物)
existing medications the ultimate goal: to provide effective,
accessible and affordable medicines for all
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3. Evolution of new drug
① In the past, drugs were extracted from plant and animal sources, but the purity of drugs was very limited. quinine（奎宁）: extracted from the bark of cinchona （金鸡纳树皮）, its antimalarial（抗疟疾） function was discovered by the Indians in North Americally synthesized drugs became available, the purity of drugs were remarkably promoted which increased the specificity of action .
e.g. quinine can be artificially synthesized in 1945 Nowadays most western medicines are totally synthesized or semi-synthesized
Unit one Txt A
Development of new drugs
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New words and expression
acute: acute infection（急性感染）, acute leukemia（急性白血病） chronic: chronic gastritis（慢性胃炎）
agonist: stimulator antagonist: blocker
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Thalidomide --------a big tragedy !
Thalidomide was developed by a German pharmaceutical company. It was sold from 1957 to 1961 in almost 50 countries under at least 40 brand names. Thalidomide was chiefly sold and prescribed to pregnant women, as an antiemetic(止吐药) to combat morning sickness and as an aid to help them sleep。In 1961 when thalidomide was withdrawn from the market, more than ten thousand deformed babies were born. They suffered from phocomelia(海豹肢).
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4. Regulation of drug development
The range of novel chemical entities developed has occasionally led to unexpected toxicity. In order to ensure the safety and efficacy of new drugs, their development must follow statutory procedures（法定程序）.
in-vitro（体外）: outside of organisms in vivo（体内）: within a whole living organism
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1.What is a new drug?
New drug
Chemical structure（化 学成分）
Dosage form(剂型）
Route of administration （给药途径）
Indication（适应症）
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2.Why do we need new drugs?
many incurable diseases still await conquest to produce new drugs that are superior than