呼吸照护药理学简介.pptVIP

Opium alkaloids 鴉片鹼: poppy seed /wiki Sources of Drugs (Ⅱ)藥物的來源 Animal:Thyroid hormone,insulin,pancreatic dornase Plant : khellin (Ammi visnaga), atropine(belladonna alkaloid), digitalis(foxglove), reserpine(Rauwolfia serpentine), volatile oil of eucalyptus, pine, anise Mineral : Copper sulfate, magnesium sulfate(epsom  salts), mineral oil (liquid bydrocarbons) Process of Drug Approval in The United States(美國的藥物核准程序)(Ⅰ) 1.Length : 13-15 y/o (chemical synthesis marketing approval by FDA, in 1980s) 2.Cost : $350 million $500million (含失敗的例子，成功率1/1000) Major Steps in the Process of Marketing a drug in the United States Isolation and Identification of the Chemical Animal studies General effects Special effects on organ systems Toxicology studies Investigational New Drug (IND) Phase 1 studies: Small number, healthy subjects Phase 2 studies: Small number, subjects with disease Phase 3 studies: Large, multicenter studies New Drug Application(NDA) Reporting system for first 6 months Process of Drug Approral in The United States(美國的藥物核准程序)(Ⅱ) Chemical Identification Identify a chemical with the potential for useful physiological effects Ex: Paclitaxel (Taxol): needles and bark of the western yew tree Rau’s Respiratory Care Pharmacology. 7th edition, 2008, Mosby /wiki Animal Studies動物實驗 1.General effect on -Organisms -Specific organs: liver, kidneys 2.Toxicology study -mutagenicity -teratogenicity -effect on reproductive fertility -carcinogenicity Investigational New Drug Approval 1.化學物經動物實驗後，向FDA申請為Investigational New Drug(IND)試驗性新藥 2.進行人體試驗分三步驟，三年內完成 Phase 1 : small group of healthy volunteers, establish its  activity (pharmacokinetic description:rates of  absorption,distribution, metabolism, elimination) Phase 2 : treatment for a small number of individuals with