安徽医科大学国际教育学院教案与讲稿 person,whose liver or kidney is disfunctional, or cardiopulmonary function is not complete. Children,pregnant or lactation women and the person with drug allergy. [Assessment of responsel 2min There are 4 grades:cure or clinical relief,excellence,improvement,failure. Efficient(%):the number of(cure +excellence)/the number of total cases*100% Some individual cases,which can't be evaluated,should be listed. [Adverse reaction evaluation 3min Adverse reactions includes clinical and laboratory abnormal reaction. Three type,namely A,B and C. Type A reaction:strong pharmacological function drug or the interaction with other drugs. Type A response could be observed or examined in clinical trials. Type B reaction,can be life-threatening and can't be predicted. Once happen,should be reported immediately to the organizer and drug management department. Type C reaction often appears with disease,and is not found or perceived in drugs trials,and is found through the epidemiological study. Phase III clinical triall 2min Phase IlI clinical trial is the stage for confirmation effect. Its purpose: to test the effect and safety of drug further, to provide adequate basis for drug registration eventually.Generally,phase III clinical trial should be random,blinded and controlled trial with sufficient sample size. [Phase IV clinical trial] 3min Phase IV clinical trial is the clinical trials of postmarketing,namely postmarketing surveillance Its purpose is: (1)To investigate the curative effect and adverse reaction under the condition of widespread administration; (2)To evaluate the relationship between benefits and risks; (3)To improve administration dosage; (4)To know of the response,indications and adverse reaction further, (5)To guide clinical rational drug administration. [Drug bioequivalence test-The purpose and significance of bioavailability test] 4min (1)To guide drug production; (2)To guide doctor to use drug rationally, (3)To seek new drug invalid(无效)or poisoning(中毒)reasons, (4)To provide a basis in evaluating the rationality of prescription drugs. (5)To evaluate the bioequivalence of copy drug; (6)To observe the influence of food on drug absorption; (7)To observe the influence of a drug on another drug absorption; (8)To observe the influence of age or disease on drug absorption; (9)To evaluate the first effect of drugs; (10)To observe drug interactions. 6安徽医科大学国际教育学院教案与讲稿 6 person, whose liver or kidney is disfunctional, or cardiopulmonary function is not complete. Children, pregnant or lactation women and the person with drug allergy. [Assessment of response] 2min There are 4 grades: cure or clinical relief, excellence, improvement, failure. Efficient (%) : the number of (cure + excellence)/the number of total cases*100% Some individual cases, which can't be evaluated, should be listed. [Adverse reaction evaluation ] 3min Adverse reactions includes clinical and laboratory abnormal reaction. Three type, namely A, B and C. Type A reaction： strong pharmacological function drug or the interaction with other drugs. Type A response could be observed or examined in clinical trials. Type B reaction, can be life-threatening and can't be predicted. Once happen, should be reported immediately to the organizer and drug management department. Type C reaction often appears with disease, and is not found or perceived in drugs trials, and is found through the epidemiological study. [Phase III clinical trial] 2min Phase III clinical trial is the stage for confirmation effect. Its purpose： to test the effect and safety of drug further, to provide adequate basis for drug registration eventually. Generally, phase III clinical trial should be random, blinded and controlled trial with sufficient sample size. [Phase IV clinical trial] 3min Phase IV clinical trial is the clinical trials of postmarketing, namely postmarketing surveillance. Its purpose is: (1)To investigate the curative effect and adverse reaction under the condition of widespread administration; (2) To evaluate the relationship between benefits and risks; (3) To improve administration dosage; (4) To know of the response, indications and adverse reaction further, (5) To guide clinical rational drug administration. [Drug bioequivalence test-The purpose and significance of bioavailability test] 4min (1) To guide drug production; (2) To guide doctor to use drug rationally; (3) To seek new drug invalid（无效） or poisoning （中毒）reasons; (4) To provide a basis in evaluating the rationality of prescription drugs. (5) To evaluate the bioequivalence of copy drug; (6) To observe the influence of food on drug absorption; (7) To observe the influence of a drug on another drug absorption; (8) To observe the influence of age or disease on drug absorption; (9) To evaluate the first effect of drugs; (10) To observe drug interactions