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【正文】 l changes submitted by the Investigator NY/VI AETC Human Subjects’ Protection ? Review reports of deaths, and serious and unexpected adverse events received from the Investigator ? Conduct periodic continuing review of the study, study risks, selection of subjects, privacy of subjects, confidentiality of data, and the consent process IRB Responsibilities (continued): NY/VI AETC Historical Minute: Origin of IRBs amp。 all equally share benefits amp。 mainly effectiveness 33% Phase III 100s – several 1000 14 yrs. Safety, dosage amp。 collect data that will allow it to be used safely ? Phase IV: Done after rx/tx has been marketed studies continue to test rx/tx to collect data about effects in various populations amp。 further evaluate safety NY/VI AETC Phases of Clinical Trials (cont.) ? Phase III: Rx/tx given to even larger group [1,0003,000] to fulfill all of Phase II objectives amp。 risks ? May withdraw at any time ? Enrollment 100% voluntary NY/VI AETC Phases of Clinical Trials ? Most trials that involve new drugs go through a series of steps: – 1: Experiments in the laboratory – 2: Once deemed safe, go through 14 phases NY/VI AETC Phases of Clinical Trials ? Phase I: Small group [2080] for 1st time to evaluate safety, determine safe dosage range amp。 low dose vs. high dose ? Specific inclusion/exclusion criteria ? Sample size amp。 others = controls ? Protocol: Study design instructions ? Blinded: Participants do not know if in experimental or control group ? Double Blinded: Participants AND staff do not know group assignment ? Placebo: Inactive pill w/ no therapeutic value NY/VI AETC Components of Clinical Trial Protocols ? Investigating two or more conditions so have two(+) groups ? Ex: drug vs. placebo。 build on that knowledge ? Test a certain hypothesis ? Study protocol must be built on sound amp。 limes for scurvy [1747] NY/VI AETC Historical Minute First “Clinical Trials” Historical Highlights of Drug Trials ? 1909: Paul Ehrlich Arsphenamine ? 1929: Alexander Fleming Penicillin ? 1935: Gerhard Domagk Sulfonamide ? 1944: Schatz/Bugie/Waksman – Streptomycin ? By 1950, the British Medical Res. Council developed a systematic methodology for studying amp。 Hypothesis Testing ? Ex: Cohort Studies, Case Control Studies ? Clinical Trials ? Ex: Investigation of Treatment/Condition ? Ex: Drug Trials NY/VI AETC The Different Study Designs ? Casecontrol ? Cohort ? Case Reports ? Case Series ? Outes Based: ? Survey Research: Quality of Life Questionnaires Decision analysis Polls Economic Analysis Surveys ? Meta Analyses ? Survival Analysis ? Randomized Clinical Trial NY/VI AETC Basic Research Terminology ? Retrospective: Refers to tim
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